Adjustable intraocular lenses and methods of post-operatively adjusting intraocular lenses

ABSTRACT

Disclosed are adjustable intraocular lenses and methods of adjusting intraocular lenses post-operatively. In one embodiment, an adjustable intraocular lens can comprise an optic portion and a peripheral portion. The peripheral portion can comprise a composite material comprising an energy absorbing constituent and a plurality of expandable components. A base power of the optic portion can be configured to change in response to an external energy directed at the composite material.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.17/060,940 filed on Oct. 1, 2020, which claims the benefit of U.S.Provisional Application No. 62/911,039 filed on Oct. 4, 2019, thecontents of which are incorporated herein by reference in theirentireties.

TECHNICAL FIELD

The present disclosure relates generally to the field of intraocularlenses, and, more specifically, to adjustable intraocular lenses andmethods of adjusting intraocular lenses post-operatively.

BACKGROUND

A cataract is a condition involving the clouding over of the normallyclear lens of a patient's eye. Cataracts occur as a result of aging,hereditary factors, trauma, inflammation, metabolic disorders, orexposure to radiation. Age-related cataract is the most common type ofcataracts. In treating a cataract, the surgeon removes the crystallinelens matrix from the patient's lens capsule and replaces it with anintraocular lens (IOL).

However, current IOL surgery may leave some patients unsatisfied withtheir refractive outcomes. In some cases, the pre-operative biometrymeasurements made on a patient's eye may be incorrect, leading to IOLswith the wrong lens power being prescribed and implanted within thepatient. In other cases, once an IOL is implanted within the capsularbag, an aggressive healing response by tissue within the capsular bagcan affect the optical power of the IOL. Moreover, a patient's cornea ormuscles within the eye may change as a result of injury, disease, oraging. In such cases, it may also be necessary to adjust the patient'simplanted IOLs to account for such changes.

Therefore, a solution is needed which allows for post-implant adjustmentof IOLs to address the aforementioned problems without having to undergoadditional surgery. Such a solution should not be overly complicated andstill allow the IOLs to be cost-effectively manufactured.

SUMMARY

Disclosed herein are adjustable intraocular lenses and methods ofadjusting intraocular lenses post-operatively. Such adjustableintraocular lenses can also be referred to as adjustable static-focusintraocular lenses or non-accommodating fluid-adjustable intraocularlenses.

In one embodiment, an intraocular lens is disclosed comprising an opticportion and a peripheral portion coupled to the optic portion. Theperipheral portion can comprise a composite material comprising anenergy absorbing constituent and a plurality of expandable components. Abase power of the optic portion can be configured to change in responseto an external energy directed at the composite material. The base powerof the optic portion can be configured to be unresponsive to forcesapplied to the peripheral portion by a capsular bag when the intraocularlens is implanted within the capsular bag.

In some embodiments, the expandable components can be expandablemicrospheres. Each of the expandable microspheres can comprise a blowingagent contained within a thermoplastic shell. A thickness of thethermoplastic shell can be configured to change in response to theexternal energy directed at the composite material.

In certain embodiments, the blowing agent can be a branched-chainhydrocarbon. For example, the branched-chain hydrocarbon can beisopentane. Also, for example, the thermoplastic shell can be made inpart of an acrylonitrile copolymer.

In some embodiments, the diameter of at least one of the expandablemicrospheres can be configured to increase between about 2× to about 4×in response to the external energy directed at the composite material. Avolume of at least one of the expandable components can be configured toexpand between about 10× to 50× in response to the external energydirected at the composite material.

In some embodiments, the expandable components can comprise betweenabout 5% to about 15% by weight of the composite material. For example,the expandable components comprise about 10% by weight of the compositematerial.

In some embodiments, the energy absorbing constituent can be an energyabsorbing colorant. A color of the energy absorbing colorant can bevisually perceptible when the intraocular lens is implanted within theeye.

In some embodiments, the energy absorbing colorant can be a dye. Forexample, the dye can be an azo dye. As a more specific example, the dyecan be a Disperse Red 1 dye.

In some embodiments, the energy absorbing colorant can be an energyabsorbing pigment. For example, the energy absorbing pigment can begraphitized carbon black. In certain embodiments, the energy absorbingconstituent can comprise between about 0.025% to about 1.00% by weightof the composite material.

In some embodiments, the peripheral portion can be made in part of across-linked copolymer comprising a copolymer blend. In theseembodiments, the composite material can also be made in part of thecopolymer blend.

The composite material can be cured to the cross-linked copolymer at alocation within the peripheral portion. The composite material canremain substantially fixed at the location.

The base power of the optic portion can be configured to change betweenabout ±0.05 D to about ±0.5 D in response to pulses of the externalenergy directed at the composite material. For example, the base powerof the optic portion can be configured to change by about 0.1 D inresponse to the pulses of the external energy directed at the compositematerial.

The base power of the optic portion can be configured to change in totalbetween about ±1.0 D and about ±2.0 D. The change in the base power canbe a persistent change.

In some embodiments, the external energy can be light energy. In theseembodiments, the light energy can be a laser light. The laser light canhave a wavelength of between about 488 nm to about 650 nm. For example,the laser light can be a green laser light. The green laser light canhave a wavelength of about 532 nm.

In other embodiments, the laser light can have a wavelength of betweenabout 946 nm to about 1120 nm. For example, the laser light can have awavelength of about 1030 nm. Also, for example, the laser light can havea wavelength of about 1064 nm.

In some embodiments, the laser light can be emitted by a neodymium-dopedyttrium aluminum garnet (Nd:YAG) laser. In other embodiments, the laserlight can be emitted by a femtosecond laser.

The energy absorbing constituent can be configured to transfer thermalenergy to the plurality of expandable components in response to theexternal energy directed at the composite material.

In some embodiments, the composite material can be formed as discreteperipheral components such that directing the external energy at onediscrete peripheral component causes a change in the base power of theoptic portion and directing the external energy at another discreteperipheral component also causes a change in the base power of the opticportion. In certain embodiments, the peripheral portion can comprisebetween 20 and 40 peripheral components.

The optic portion of the IOL can comprise an optic fluid chamber and theperipheral portion can comprise at least one peripheral fluid chamber influid communication with the optic fluid chamber. In some embodiments,the peripheral fluid chamber is curved and the peripheral fluid chamberfollows a curvature of the optic portion.

The peripheral fluid chamber can have a chamber height. The chamberheight can be between about 0.1 mm to about 0.3 mm.

In some embodiments, the composite material can be configured as achamber expander. The chamber expander can be configured to expand inresponse to the external energy directed at the chamber expander.Expansion of the chamber expander can increase a volume of theperipheral fluid chamber. The base power of the optic portion can beconfigured to decrease in response to the external energy directed atthe chamber expander. The chamber expander can be configured as anexpandable column extending from a chamber anterior wall to a chamberposterior wall.

In some embodiments, the composite material can be configured as aspace-filler or piston. The space-filler or piston can be configured toexpand in response to the external energy directed at the space-filleror piston. Expansion of the space-filler or piston can decrease a volumeof the peripheral fluid chamber. The space-filler or piston can beconfigured as a pad extending from either a chamber anterior wall or achamber posterior wall. The base power of the optic portion can beconfigured to increase in response to the external energy directed atthe space-filler or piston.

The base power can be configured to change in response to fluiddisplacement between the optic fluid chamber and the peripheral fluidchamber as a result of the external energy directed at the compositematerial.

In certain embodiments, the peripheral portion can comprise a firstcomposite material and a second composite material. In theseembodiments, the first composite material can comprise a first energyabsorbing constituent and the second composite material can comprise asecond energy absorbing constituent. A color of the first energyabsorbing constituent can be different from a color of the second energyabsorbing constituent.

In some embodiments, the peripheral portion can be configured as atleast one haptic and the peripheral fluid chamber can be defined withinthe haptic. In these embodiments, the peripheral fluid chamber canextend only partially into the haptic.

The haptic can comprise a haptic proximal portion and a haptic distalportion. The haptic distal portion can comprise a haptic distal armunattached to the optic portion except via the haptic proximal portion.

In some embodiments, the haptic distal arm can comprise a kink or bend.

The peripheral fluid chamber can be defined within the haptic proximalportion and a chamber segment of the haptic proximal portion can beunconnected to or separated from the optic portion by a gap or space.The haptic can be connected to the optic portion at a proximal end ofthe haptic and at a distal connecting portion located distally of thechamber segment.

In some embodiments, the proximal end of the haptic can be connected toand extend from a lateral side of the optic portion. In theseembodiments, the lateral side can have a side height of about 0.65 mm.

The peripheral portion can be configured as a first haptic comprising afirst haptic fluid chamber and a second haptic comprising a secondhaptic fluid chamber. The optic portion can comprise an optic fluidchamber.

The first haptic fluid chamber can be in fluid communication with theoptic fluid chamber via a first fluid channel. The second haptic fluidchamber can be in fluid communication with the optic fluid chamber via asecond fluid channel. The first fluid channel can be positioneddiametrically opposed to the second fluid channel.

In some embodiments, the optic fluid chamber, the first haptic fluidchamber, and the second haptic fluid chamber can comprise a fluid havinga total fluid volume of between about 10 μL and about 20 μL. Each of thefirst haptic fluid chamber and the second haptic fluid chamber cancomprise about 0.5 μL of the fluid. In certain embodiments, about 15 nLof the fluid can be exchanged between either the first haptic fluidchamber and the second haptic fluid chamber and the optic fluid chamberin response to pulses of the external energy directed at the compositematerial. In some embodiments, the fluid can be a silicone oil.

In another embodiment, an intraocular lens is disclosed comprising anoptic portion and a peripheral portion coupled to the optic portion. Theperipheral portion can comprise a first peripheral component and asecond peripheral component. The first peripheral component can be madeof a composite material comprising an energy absorbing constituent and aplurality of expandable components. The second peripheral component canalso be made of the composite material comprising the energy absorbingconstituent and the plurality of expandable components. A base power ofthe optic portion can be configured to increase in response to anexternal energy directed at the first peripheral component and the basepower of the optic portion can be configured to decrease in response tothe external energy directed at the second peripheral component.However, the base power of the optic portion can be configured to beunresponsive to forces applied to the peripheral portion by a capsularbag when the intraocular lens is implanted within the capsular bag.

In some embodiments, the optic portion can comprise an optic fluidchamber and the peripheral portion can comprise at least one peripheralfluid chamber in fluid communication with the optic fluid chamber. Thebase power can be configured to change in response to fluid displacementbetween the optic fluid chamber and the peripheral fluid chamber as aresult of the external energy directed at the first peripheral componentor the second peripheral component.

In some embodiments, the first peripheral component can be configured asa space-filler. The space-filler can be configured to expand in responseto the external energy directed at the space-filler. Expansion of thespace-filler can decrease a volume of the peripheral fluid chamber. Forexample, the space-filler can be configured as an expandable padextending from either a chamber anterior wall or a chamber posteriorwall.

In some embodiments, the second peripheral component can be configuredas a chamber expander or jack. The chamber expander or jack can beconfigured to expand in response to the external energy directed at thechamber expander or jack. Expansion of the chamber expander or jack canincrease a volume of the peripheral fluid chamber. For example, thechamber expander or jack can be configured as an expandable columnextending from a chamber anterior wall to a chamber posterior wall.

In certain embodiments, the first peripheral component and the secondperipheral component can be located within the same peripheral fluidchamber. In these embodiments, the second peripheral component can bepositioned distal to the first peripheral component within the sameperipheral fluid chamber. Also, in these embodiments, the firstperipheral component can be positioned proximal to the second peripheralcomponent within the same peripheral fluid chamber. The first peripheralcomponent can be positioned closer to a fluid channel connecting theoptic fluid chamber to the peripheral fluid chamber than the secondperipheral component.

The first peripheral component and the second peripheral component canbe configured as discrete peripheral components such that directing theexternal energy at one discrete peripheral component can cause a changein the base power of the optic portion and directing the external energyat another discrete peripheral component can also cause a change in thebase power of the optic portion.

In some embodiments, one peripheral fluid chamber can comprise at leastten first peripheral components. In these and other embodiments, thesame or another peripheral fluid chamber can comprise at least tensecond peripheral components.

A method of post-operatively adjusting an intraocular lens is alsodisclosed. The method can comprise adjusting a base power of theintraocular lens by directing an external energy at a composite materialwithin a peripheral portion of the intraocular lens. The peripheralportion can be coupled to an optic portion disposed radially inward ofthe peripheral portion. The composite material can comprise an energyabsorbing constituent and a plurality of expandable components. The basepower of the intraocular lens can be configured to be unresponsive toforces applied to the peripheral portion by a capsular bag when theintraocular lens is implanted within the capsular bag.

The optic portion can comprise an optic fluid chamber and the peripheralportion can comprise at least one peripheral fluid chamber in fluidcommunication with the optic fluid chamber. The base power of theintraocular lens can change in response to fluid displacement betweenthe optic fluid chamber and the peripheral fluid chamber as a result ofthe external energy directed at the composite material. In someembodiments, about 15 nL of fluid can be exchanged between theperipheral fluid chamber and the optic fluid chamber in response topulses of the external energy directed at the composite material.

In some embodiments, adjusting the base power of the intraocular lenscan further comprise increasing the base power by directing the externalenergy at the composite material configured as a space-filler positionedwithin a peripheral fluid chamber defined within the peripheral portion.

The method can also comprise decreasing the base power by directing theexternal energy at another instance of the composite material configuredas a chamber expander positioned within the peripheral portion.

In some embodiments, adjusting the base power of the intraocular lenscan further comprise decreasing the base power by directing the externalenergy at the composite material configured as a chamber expanderpositioned within a peripheral fluid chamber defined within theperipheral portion. Decreasing the base power can further comprisedirecting the external energy at another instance of the compositematerial configured as a space-filler positioned within the peripheralfluid chamber.

In certain embodiments, adjusting the base power of the intraocular lenscan further comprise directing pulses of the external energy at a firstperipheral component within a peripheral fluid chamber defined withinthe peripheral portion and directing additional pulses of the externalenergy at a second peripheral component within the same peripheral fluidchamber. The first peripheral component can be made of the compositematerial and the second peripheral component can be made of the samecomposite material.

In additional embodiments, adjusting the base power of the intraocularlens can further comprise directing pulses of the external energy at afirst peripheral component within a first peripheral fluid chamberdefined within the peripheral portion and directing additional pulses ofthe external energy at a second peripheral component within a secondperipheral fluid chamber defined within the peripheral portion. Thefirst peripheral component can be made of the composite material and thesecond peripheral component can be made of the same composite material.The first peripheral fluid chamber can be in fluid communication withthe second peripheral fluid chamber via an optic fluid chamber definedwithin the optic portion.

In some embodiments, adjusting the base power in a first direction canfurther comprise directing the external energy at a first compositematerial and adjusting the base power in a second direction by directingthe external energy at a second composite material. The first compositematerial can comprise a first energy absorbing constituent having afirst color. The second composite material can comprise a second energyabsorbing constituent having a second color different from the firstcolor.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a top plan view of an embodiment of an adjustableintraocular lens (IOL) with part of an anterior portion of theadjustable IOL removed to better illustrate components within the IOL.

FIG. 1B illustrates the adjustable IOL implanted within a capsular bagof a subject.

FIG. 2A illustrates a perspective view of the adjustable IOL.

FIG. 2B illustrates a perspective view of the adjustable IOL with partof the anterior portion of the adjustable IOL removed to betterillustrate components within the IOL.

FIG. 3A illustrates a sectional view of the adjustable IOL taken alongcross-section A-A of FIG. 2A.

FIG. 3B illustrates a sectional view of the adjustable IOL taken alongcross-section B-B of FIG. 2A.

FIG. 3C illustrates an external energy directed at a first peripheralcomponent of the adjustable IOL.

FIG. 3D illustrates an external energy directed at a second peripheralcomponent of the adjustable IOL.

FIG. 4A illustrates a composite material used to make at least part ofthe adjustable intraocular lens.

FIG. 4B illustrates one embodiment of an expandable component of theadjustable intraocular lens.

FIG. 5 illustrates a top plan view of another embodiment of theadjustable IOL with part of the anterior portion of the adjustable IOLremoved to better illustrate components within the IOL.

FIG. 6 illustrates a top plan view of the adjustable IOL with a lightsplitting lens surface profile.

FIG. 7 is one embodiment of a method of adjusting an IOLpost-operatively.

FIG. 8 is another embodiment of a method of adjusting an IOLpost-operatively.

FIG. 9 is yet another embodiment of a method of adjusting an IOLpost-operatively.

FIG. 10 is an additional embodiment of a method of adjusting an IOLpost-operatively.

DETAILED DESCRIPTION

FIG. 1A illustrates a top plan view of an embodiment of an adjustablestatic-focus intraocular lens (IOL) 100 with part of an anterior portionof the adjustable IOL 100 removed to better illustrate components withinthe IOL. As depicted in FIG. 1A, the adjustable IOL 100 can comprise anoptic portion 102 and a peripheral portion 103. The peripheral portion103 can comprise one or more haptics 104 including a first haptic 104Aand a second haptic 104B extending peripherally from or coupled to theoptic portion 102.

For example, the adjustable IOL 100 can be a one-piece lens (see, e.g.,FIGS. 1A-3B) such that the peripheral portion 103 is connected to andextends from the optic portion 102. In this example embodiment, theperipheral portion 103 is formed along with the optic portion 102 and isnot adhered or otherwise coupled to the optic portion 102 in asubsequent step.

In other embodiments, the peripheral portion 103 is coupled to andadhered to the optic portion 102. For example, the peripheral portion103 can be adhered to the optic portion 102 after each is formedseparately.

The optic portion 102 can comprise an optic fluid chamber 106 (see also,e.g., FIGS. 2B, 3A, and 3B) and one or more peripheral fluid chambers108 in fluid communication with the optic fluid chamber 106. The one ormore peripheral fluid chambers 108 can be defined within the peripheralportion 103. For example, the at least one peripheral fluid chamber 108can extend into the peripheral portion 103.

In some embodiments, the at least one peripheral fluid chamber 108 canextend only partially into the peripheral portion 103. For example, theat least one peripheral fluid chamber 108 can extend only partially intoone-third, one-half, or three-quarters of the peripheral portion 103.Also, for example, the at least one peripheral fluid chamber 108 canextend only partially into between one-third and one-half of theperipheral portion 103 or between one-half and three-quarters of theperipheral portion 103.

In certain embodiments, the at least one peripheral fluid chamber 108can extend only partially into one of the haptics 104 of the peripheralportion 103. For example, the at least one peripheral fluid chamber 108can extend only partially into one-third, one-half, or three-quarters ofthe haptic 104. Also, for example, the at least one peripheral fluidchamber 108 can extend only partially into between one-third andone-half of the haptic 104 or between one-half and three-quarters of thehaptic 104.

As shown in FIG. 1A, the peripheral portion 103 can comprise two haptics104 (e.g., a first haptic 104A and a second haptic 104B). In thisembodiment, a peripheral fluid chamber 108 can extend into each of thetwo haptics 104. The peripheral fluid chamber 108 can extend onlypartially into haptic 104.

The one or more peripheral fluid chambers 108 can also be referred to asone or more haptic fluid chambers. When the peripheral portion 103comprises a first haptic 104A and a second haptic 104B, the peripheralportion 103 can comprise one peripheral fluid chamber 108 referred to asa first haptic fluid chamber and another peripheral fluid chamber 108referred to as a second haptic fluid chamber.

At least one of the haptics 104 (e.g., the first haptic 104A, the secondhaptic 104B, or a combination thereof) can be curved. In theseembodiments, the peripheral fluid chamber 108 (e.g., the haptic fluidchamber) can be curved. The peripheral fluid chamber 108 can follow acurvature of the haptic 104. The peripheral fluid chamber 108 can alsofollow a curvature of the optic portion 102 when at least a segment ofthe haptic 104 follows a curvature of at least part of the optic portion102.

The peripheral fluid chamber 108 can be in fluid communication with theoptic fluid chamber 106 or fluidly coupled to the optic fluid chamber106 via a fluid channel 110. The fluid channel 110 can be a passagewayor conduit connecting the peripheral fluid chamber 108 to the opticfluid chamber 106. The fluid channel 110 can be defined along theposterior element 300 (see, e.g., FIGS. 3A and 3B) of the optic portion102.

The fluid channel 110 can also refer to a gap or opening defined along alateral side 111 or lateral surface (see also, e.g., FIGS. 2A, 2B, 3A,and 3B) of the optic portion 102. The fluid channel 110 can be curved.The fluid channel 110 can be substantially shaped as an annular segment.

The peripheral fluid chamber 108 can be in fluid communication with theoptic fluid chamber 106 or fluidly coupled to the optic fluid chamber106 via a singular fluid channel 110. When the adjustable IOL 100comprises multiple peripheral fluid chambers 108, each of the peripheralfluid chambers 108 can be in fluid communication with the optic fluidchamber 106 or fluidly coupled to the optic fluid chamber 106 via asingular fluid channel 110.

In other embodiments, the peripheral fluid chamber 108 can be in fluidcommunication with the optic fluid chamber 106 or fluidly coupled to theoptic fluid chamber 106 via a plurality (e.g., two or more) of fluidchannels. In these embodiments, the two or more fluid channels 110 canbe separated by a channel divider or dividing wall.

When the peripheral portion 103 comprises a first haptic 104A having afirst haptic fluid chamber and a second haptic 104B having a secondhaptic fluid chamber, the first haptic fluid chamber can be in fluidcommunication or fluidly coupled to the optic fluid chamber 106 via afirst fluid channel and the second haptic fluid chamber can be in fluidcommunication or fluidly coupled to the optic fluid chamber 106 via asecond fluid channel. In these embodiments, the first fluid channel canbe positioned diametrically opposed to the second fluid channel (see,e.g., FIGS. 1A, 1B, 2B, and 3A).

FIG. 1A illustrates that when the peripheral portion 103 is implementedas one or more haptics 104, each of the haptics 104 can have a hapticproximal portion 112 and a haptic distal portion 114. The peripheralfluid chamber 108 or the haptic fluid chamber can be defined within thehaptic proximal portion 112.

At least a segment of the haptic proximal portion 112 can be curved. Atleast a segment of the haptic proximal portion 112 can follow acurvature of at least part of the optic portion 102.

The haptic distal portion 114 can comprise a haptic distal arm 116. Thehaptic distal arm 116 can be unattached to the optic portion 102 exceptvia the haptic proximal portion 112.

The haptic distal arm 116 can comprise a kink or bend 118 defined alongthe haptic distal arm 116. The kink or bend 118 can allow the hapticdistal arm 116 to compress or flex in response to capsular bagreshaping. The haptic distal arm 116 can terminate at a free orunconnected haptic distal end 120.

When the peripheral portion 103 comprises two haptics 104 (e.g., a firsthaptic 104A and a second haptic 104B), the adjustable IOL 100 can havean uncompressed haptic length 122 as measured from a haptic distal end120 of the first haptic 104A to the haptic distal end 120 of the secondhaptic 104B. The uncompressed haptic length 122 can be between about12.0 mm and about 14.0 mm. For example, the uncompressed haptic length122 can be about 13.0 mm.

The haptic distal end 120 of each of the haptics 104 can be a closed endof the haptic 104 unconnected to the optic portion 102. The hapticdistal end 120 can comprise a bulbous feature or nodule at the terminusof the haptic distal end 120.

As shown in FIG. 1A, the optic portion 102 can have an optic portiondiameter 124. The optic portion diameter 124 can be between about 5.0 mmand 8.0 mm. For example, the optic portion diameter 124 can be about 6.0mm.

The haptic 104 can be connected to the optic portion 102 at a proximalend 126 of the haptic 104. The haptic 104 can also be connected to theoptic portion 102 at a distal connecting portion 128. The distalconnecting portion 128 can be portion of the haptic 104 located distallyof a distal end of the peripheral fluid chamber 108 or haptic fluidchamber.

A segment of the haptic 104 in between the proximal end 126 and thedistal connecting portion 128 (herein referred to as a chamber segment129) can be physically separated from the optic portion 102. The chambersegment 129 can comprise at least a segment of the peripheral fluidchamber 108 in between a radially inner chamber wall 132 and a radiallyouter chamber wall 134. For example, the radially inner chamber wall 132of the chamber segment 129 can be separated from the optic portion 102by an elongate gap or space. The elongate gap or space can be a curvedgap 130, as shown in FIG. 1A.

The curved gap 130 can allow the peripheral fluid chamber 108 or hapticfluid chamber to expand or change shape without the radially innerchamber wall 132 impinging against or applying pressure to the lateralside 111 (see also, e.g., FIGS. 2A, 2B, 3A, and 3B) of the optic portion102 adjacent to the chamber segment 129.

As shown in FIG. 1A, the radially outer chamber wall 134 can be thickeror bulkier than the radially inner chamber wall 132. In someembodiments, the radially outer chamber wall 134 can be thicker orbulkier than both the radially inner chamber wall 132 and the peripheralfluid chamber 108.

The thick or bulky radially outer chamber wall 134 can provide thechamber segment 129 with stiffness or resiliency when forces are appliedto the chamber segment 129 in the radial direction by capsular bagcontraction or reshaping. For example, the thick or bulky radially outerchamber wall 134 can allow the chamber segment 129 of the peripheralportion 103 to be insensitive or be less sensitive to radial forcesapplied to the peripheral portion 103 in the radial direction bycapsular bag reshaping caused by ciliary muscle movements.

In some embodiments, the distal connecting portion 128 can be unfixed orunconnected to an adjacent section of the optic portion 102, thusallowing a greater amount of the haptic 104 to freely move for foldingor splaying purposes during implantation of the IOL 100. Once the IOL100 is implanted within the capsular bag, the distal connecting portion128 can rest against or otherwise contact the adjacent section of theoptic portion 102 to stabilize the haptic 104 and prevent the haptic 104from twisting or otherwise moving around in response to capsular bagcontractions or reshaping. In other embodiments, the haptic 104 can alsobe connected to the optic portion 102 at the distal connecting portion128.

As shown in FIG. 1A, the peripheral fluid chamber 108 can terminatebefore reaching the haptic distal portion 114. In some embodiments, thehaptic distal arm(s) 116 can be made of the same material as the hapticchamber walls.

One technical problem faced by the applicants is how to design afluid-filled IOL that can be adjusted post-operatively by a clinician orother medical professional, but that would not be responsive to, or thusinsensitive to, radial forces applied to the fluid-filled IOL by thecapsular bag. One solution discovered by the applicants is theadjustable IOL disclosed herein with a peripheral fluid chamber thatextends only partially into the haptic of the adjustable IOL and achamber segment of the haptic having a radially outer chamber wallthicker than a radially inner chamber wall and the radially innerchamber wall separated from the optic portion by an elongate gap orspace. The haptic can also be connected to the optic portion at a hapticproximal end and a distal connecting portion located distally of thechamber segment.

The peripheral portion 103 can comprise a composite material 400 (see,e.g., FIG. 4A) or at least part of the peripheral portion 103 can bemade of the composite material 400. As will be discussed in more detailin the following sections, the composite material 400 can comprise anenergy absorbing constituent 404 and a plurality of expandablecomponents 406 (see, e.g., FIGS. 4A and 4B).

In some embodiments, the composite material 400 can be configured as aplurality of space-fillers 310 (see, e.g., FIGS. 3A and 3B) or pistons.One or more of the space-fillers 310 can be configured to expand inresponse to an external energy 318 (see, e.g., FIG. 3C) directed at theone or more space-fillers 310. Expansion of the one or morespace-fillers 310 can decrease a volume of a peripheral fluid chamber108 housing the one or more space-fillers 310. At least one of thespace-fillers 310 can be configured as a pad extending from either achamber anterior wall 314 or a chamber posterior wall 316 of theperipheral fluid chamber 108 (see, e.g., FIG. 3B).

In these and other embodiments, the composite material 400 can beconfigured as a plurality of chamber expanders 312 (see, e.g., FIG. 3B)or jacks. One or more of the chamber expanders 312 can be configured toexpand in response to an external energy 318 (see, e.g., FIG. 3D)directed at the one or more chamber expanders 312. Expansion of the oneor more chamber expanders 312 can increase a volume of the peripheralfluid chamber 108 housing the one or more chamber expanders 312. Atleast one of the chamber expanders 312 can be configured as anexpandable column extending from a chamber anterior wall 314 to achamber posterior wall 316 of the peripheral fluid chamber 108 (see,e.g., FIG. 3B).

A base power or optical/dioptric power of the optic portion 102 can beconfigured to change in response to an external energy 318 (see, e.g.,FIGS. 3C and 3D) directed at the composite material 400. However, thebase power of the optic portion 102 can be unresponsive or insensitiveto forces applied to the peripheral portion 103 by the capsular bag whenthe adjustable IOL 100 is implanted within the capsular bag.

The base power of the optic portion 102 can be configured to change inresponse to fluid being displaced between the optic fluid chamber 106and the peripheral fluid chamber 108 as a result of the external energy318 directed at the composite material 400.

The composite material 400 of the peripheral portion 103 can be formed,shaped, or otherwise configured as a plurality of discrete peripheralcomponents 136. For example, each of the peripheral components 136 canbe separated from neighboring or adjacent peripheral components 136 byspaces or gaps.

The peripheral components 136 can be positioned or located within theperipheral fluid chamber(s) 108. In some embodiments, the peripheralcomponents 136 can occupy the entire chamber length of the peripheralfluid chamber 108. In other embodiments, the peripheral components 136can occupy only part of the peripheral fluid chamber 108.

In some embodiments, directing external energy 318 at one of theperipheral components 136 can cause that particular peripheral component136 to change its shape or expand without substantially affecting theother peripheral components 136. For example, directing the externalenergy 318 at one of the peripheral components 136 can cause thatparticular peripheral component 136 to change its shape or expandwithout causing a similar shape change or expansion in the otherperipheral components 136.

Pulses or a set amount of the external energy 318 can be directed at oneperipheral component 136 in order to cause a change in the base power ofthe optic portion 102. In these embodiments, additional pulses or anadditional amount of the external energy 318 can be directed at anotherperipheral component 136 in order to cause another change in the basepower of the optic portion 102.

In some embodiments, the peripheral portion 103 can comprise between 20and 40 peripheral components 136. In other embodiments, the peripheralportion 103 can comprise between 10 and 20 peripheral components 136. Inadditional embodiments, the peripheral portion 103 can comprise between40 and 60 peripheral components 136.

In certain embodiments, one peripheral fluid chamber 108 can comprise 20peripheral components 136. In other embodiments, one peripheral fluidchamber 108 can comprise between 10 and 20 peripheral components 136. Infurther embodiments, one peripheral fluid chamber 108 can comprisebetween 20 and 30 peripheral components 136. In additional embodiments,one peripheral fluid chamber 108 can comprise between 5 and 10peripheral components 136.

The peripheral components 136 can comprise one or more first peripheralcomponents 138, one or more second peripheral components 140, or acombination thereof. The first peripheral component(s) 138 and thesecond peripheral component(s) 140 can be positioned or located withinthe same peripheral fluid chamber 108.

In some embodiments, one peripheral fluid chamber 108 can comprise atleast ten first peripheral components 138. In other embodiments, oneperipheral fluid chamber 108 can comprise between five and ten firstperipheral components 138 or between ten and twenty first peripheralcomponents 138.

In these and other embodiments, one peripheral fluid chamber 108 cancomprise at least ten second peripheral components 140. In otherembodiments, one peripheral fluid chamber 108 can comprise between fiveand ten second peripheral components 140 or between ten and twentysecond peripheral components 140.

In the embodiment shown in FIG. 1A, one peripheral fluid chamber 108 cancomprise ten first peripheral components 138 and ten second peripheralcomponents 140. Moreover, the adjustable IOL 100 can comprise twohaptics 104 with each haptic comprising a haptic fluid chamber havingten first peripheral components 138 and ten second peripheral components140.

The first peripheral components 138 can be positioned proximal to thesecond peripheral components 140 within the peripheral fluid chamber 108(that is, the second peripheral components 140 can be positioned deeperwithin the peripheral fluid chamber 108). For example, the firstperipheral components 138 can be positioned closer to a fluid channel110 connecting the optic fluid chamber 106 to the peripheral fluidchamber 108 than the second peripheral components 140. One reason toposition the second peripheral components 140 (e.g., the chamberexpanders 312 or jacks) deeper or more distal in the peripheral fluidchamber 108 is to minimize the mechanical stresses placed on the opticportion 102 (which can cause unwanted aberrations) since expansion ofthe second peripheral components 140 affects the whole cross-section ofthe peripheral fluid chamber 108.

In other embodiments, at least some of the second peripheral components140 can be positioned more proximal or closer to the fluid channel 110than the first peripheral components 138. In further embodiments, thefirst peripheral components 138 can be interleaved with the secondperipheral components 140 such that the components form an alternatingpattern.

In the embodiment shown in FIG. 1A, the peripheral components 136(including the first peripheral components 138, the second peripheralcomponents 140, or a combination thereof) can be arranged in a singlefile (e.g., a single curved file) along a length of the peripheral fluidchamber 108. In other embodiments not shown in the figures butcontemplated by this disclosure, the peripheral components 136 can bearranged in a zig-zag, a winding pattern, or a double or triple filepattern, i.e., two or more adjacent rows of peripheral components 136.

The base power of the optic portion 102 can be configured to change inresponse to fluid displacement between the optic fluid chamber 106 andthe peripheral fluid chamber 108 as a result of an external energy 318directed at the peripheral component(s) 136. For example, fluid can flowout of the peripheral fluid chamber 108 and into the optic fluid chamber106 or flow out of the optic fluid chamber 106 and back into theperipheral fluid chamber 108 in response the external energy 318directed at the peripheral component(s) 136.

The base power of the optic portion 102 can be configured to change in afirst direction in response to an external energy 318 directed at thefirst peripheral component 138. The base power of the optic portion 102can also be configured to change in a second direction opposite thefirst direction in response to an external energy 318 directed at thesecond peripheral component 140.

For example, the base power of the optic portion 102 can be configuredto increase in response to external energy 318 directed at the firstperipheral component 138. As a more specific example, fluid within theperipheral fluid chamber 108 can flow into the optic fluid chamber 106in response to the external energy directed at the first peripheralcomponent 138.

Also, for example, the base power of the optic portion 102 can beconfigured to decrease in response to external energy 318 directed atthe second peripheral component 140. As a more specific example, fluidwithin the optic fluid chamber 106 can flow into the peripheral fluidchamber 108 in response to the external energy directed at the secondperipheral component 140.

As will be discussed in more detail in the following sections, the firstperipheral component 138 can be configured as a space-filler 310 (see,e.g., FIGS. 3A and 3B) or piston. The space-filler 310 can be configuredto expand in response to external energy 318 directed at thespace-filler 310. Expansion of the space-filler 310 can decrease avolume of the peripheral fluid chamber 108, which may therefore causefluid to migrate from the peripheral fluid chamber 108 to the opticfluid chamber 106.

The second peripheral component 140 can be configured as a chamberexpander 312 (see, e.g., FIGS. 2B, 3A, and 3B) or jack. The chamberexpander 312 can be configured to expand in response to external energy318 directed at the chamber expander 312. Expansion of the chamberexpander 312 can increase a volume of the peripheral fluid chamber 108.

In some embodiments, the fluid within the optic fluid chamber 106, theperipheral fluid chamber(s) 108, or a combination thereof can be an oil.More specifically, in certain embodiments, the fluid within the opticfluid chamber 106, the peripheral fluid chamber(s) 108, or a combinationthereof can be a silicone oil or fluid.

The fluid within the optic fluid chamber 106, the peripheral fluidchamber(s) 108, or a combination thereof can be a silicone oil or fluidcomprising or made in part of diphenyl siloxane and dimethyl siloxane.In other embodiments, the silicone oil or fluid can comprise or be madein part of a ratio of two dimethyl siloxane units to one diphenylsiloxane unit. In certain embodiments, the silicone oil can compriseabout 20 mol % diphenyl siloxane and about 80 mol % dimethyl siloxane.

More specifically, in some embodiments, the silicone oil can comprisediphenyltetramethyl cyclotrisiloxane. In additional embodiments, thesilicone oil or fluid can comprise or be made in part of a diphenylsiloxane and dimethyl siloxane copolymer.

The fluid (e.g., the silicone oil) can be index matched with the lensbody material used to make the optic portion 102. When the fluid isindex matched with the lens body material, the entire optic portion 102containing the fluid acts as a single lens. For example, the fluid canbe selected so that it has a refractive index of between about 1.48 and1.53 (or between about 1.50 and 1.53). In some embodiments, the fluid(e.g., the silicone oil) can have a polydispersity index of betweenabout 1.2 and 1.3. In other embodiments, the fluid (e.g., the siliconeoil) can have a polydispersity index of between about 1.3 and 1.5. Inother embodiments, the fluid (e.g., the silicone oil) can have apolydispersity index of between about 1.1 and 1.2. Other example fluidsare described in U.S. Patent Publication No. 2018/0153682, which isherein incorporated by reference in its entirety.

FIG. 1B illustrates that the adjustable static-focus IOL 100 can beimplanted within a native capsular bag in which a native lens has beenremoved. When implanted within the native capsular bag, the opticportion 102 can be adapted to refract light that enters the eye onto theretina. The one or more haptics 104 (e.g., the first haptic 104A and thesecond haptic 104B) can be configured to engage the capsular bag to holdthe adjustable IOL 100 in place within the capsular bag.

FIG. 2A illustrates a perspective view of the adjustable IOL 100. Aspreviously discussed, the optic fluid chamber 106 and the peripheralfluid chamber(s) 108 can be filled with a fluid (e.g., silicone oil).The base power of the optic portion 102 can be configured to changebased on an internal fluid pressure within the fluid-filled optic fluidchamber 106.

The optic portion 102 can also be configured to change shape in responseto fluid entering the optic fluid chamber 106. In certain embodiments,an anterior element 200 of the optic portion 102 can be configured tochange shape in response to fluid entering or exiting the optic fluidchamber 106. For example, the anterior element 200 can be configured toincrease its curvature in response to fluid entering the optic fluidchamber 106. Also, for example, the anterior element 200 can beconfigured to decrease its curvature in response to fluid exiting theoptic fluid chamber 106.

In other embodiments, a posterior element 300 (see, e.g., FIGS. 3A and3B) of the optic portion 102 can be configured to change shape (e.g.,increase its curvature or decrease its curvature) in response to fluidentering or exiting the optic fluid chamber 106. In further embodiments,both the anterior element 200 and the posterior element 300 can beconfigured to change shape in response to the fluid entering or exitingthe optic fluid chamber 106.

The base power of the optic portion 102 can be configured to increase ordecrease in response to shape change(s) undertaken by the anteriorelement 200, the posterior element 300, or a combination thereof.Increasing the curvature of the anterior element 200, the posteriorelement 300, or a combination thereof can increase a base dioptric powerof the optic portion 102 allowing for better near vision. Decreasing thecurvature of the anterior element 200, the posterior element 300, or acombination thereof can decrease a base dioptric power of the opticportion 102 allowing for better distance vision.

For example, the base power of the optic portion 102 can be configuredto increase as fluid enters the optic fluid chamber 106 from theperipheral fluid chamber(s) 108 (e.g., the haptic fluid chamber(s)).Fluid can flow from the peripheral fluid chamber(s) 108 into the opticfluid chamber 106 as the volume of the peripheral fluid chamber(s) 108decreases in response to an expansion of one or more of the firstperipheral components 138. One or more of the first peripheralcomponents 138 can expand in response to an external energy 318 directedat the first peripheral component(s) 138.

Also, for example, the base power of the optic portion 102 can beconfigured to decrease as fluid exits or is drawn out of thefluid-filled optic fluid chamber 106 into the peripheral fluidchamber(s) 108. Fluid can flow from the optic fluid chamber 106 into theperipheral fluid chamber(s) 108 as the volume of the peripheral fluidchamber(s) 108 increases in response to an expansion of one or more ofthe second peripheral components 140. One or more of the secondperipheral components 140 can expand in response to an external energy318 directed at the second peripheral component(s) 140.

FIG. 2B illustrates a perspective view of the adjustable IOL 100 withpart of the anterior portion of the adjustable IOL 100 removed to betterillustrate components within the IOL. The adjustable IOL 100 cancomprise a peripheral portion 103 comprising a plurality of peripheralcomponents 136 within the peripheral fluid chamber(s) 108. For example,parts of the peripheral portion 103 can be formed as the peripheralcomponents 136.

As shown in FIG. 2B, the optic fluid chamber 106 can be in fluidcommunication with each of the peripheral fluid chambers 108 through afluid channel 110. The fluid channel 110 can be a conduit or passagewayconnecting the optic fluid chamber 106 to the peripheral fluidchamber(s) 108 or haptic fluid chamber(s). Although a singular fluidchannel 110 is shown connecting the optic fluid chamber 106 to eachperipheral fluid chamber 108, it is contemplated by this disclosure thata plurality of fluid channels (e.g., two fluid channels) can connect theoptic fluid chamber 106 to each peripheral fluid chamber 108.

The base power of the optic portion 102 can be configured to change(e.g., increase or decrease) in response to an external energy 318directed at the peripheral components 136. As previously discussed, eachof the peripheral components 136 can be made of the composite material400.

As will be discussed in more detail in the following sections, each ofthe first peripheral components 138 can be configured as a space-filler310 (see also, e.g., 3A, 3B, and 3C). The space-filler 310 can beconfigured to expand in response to external energy directed at thespace-filler 310. Expansion of the space-filler 310 can decrease avolume of the peripheral fluid chamber 108 and causing the fluid to flowfrom the peripheral fluid chamber 108 into the optic fluid chamber 106.

Each of the second peripheral components 140 can be configured as achamber expander 312 (see also, e.g., FIGS. 3B and 3D). The chamberexpander 312 can be configured to expand in response to external energydirected at the chamber expander 312. Expansion of the chamber expander312 can increase a volume of the peripheral fluid chamber 108 byexpanding the peripheral fluid chamber 108 and causing the fluid to flowor be drawn out from the optic fluid chamber 106 into the peripheralfluid chamber 108.

The optic fluid chamber 106 and the peripheral fluid chamber(s) 108 cancomprise or hold a fluid (e.g., silicone oil) having a total fluidvolume of between about 10 μL and about 20 μL. For example, the opticfluid chamber 106 and the peripheral fluid chamber(s) 108 can comprise afluid (e.g., silicone oil) having a total fluid volume of about 15 μL.

In the embodiment shown in FIG. 2B, the peripheral portion 103 cancomprise a first haptic 104A and a second haptic 104B. The first haptic104A can have a first haptic fluid chamber and the second haptic 104Bcan have a second haptic fluid chamber. Each of the first haptic fluidchamber and the second haptic fluid chamber can be considered one of theperipheral fluid chambers 108. In this embodiment, each of the hapticfluid chambers (e.g., each of the first haptic fluid chamber and thesecond haptic fluid chamber) can comprise or hold a fluid having fluidvolume of between about 0.3 μL and 0.6 μL (or about 0.5 μL).

In some embodiments, between about 10 nanoliters (nL) and 20 nL of thefluid can be exchanged or displaced between a peripheral fluid chamber108 (for example, either the first haptic fluid chamber or the secondhaptic fluid chamber) and the optic fluid chamber 106 in response topulses of the external energy 318 directed at one of the peripheralcomponents 136. More specifically, about 15 nL of the fluid can beexchanged or displaced between one or more peripheral fluid chambers 108(for example, either the first haptic fluid chamber or the second hapticfluid chamber) and the optic fluid chamber 106 in response to pulses ofthe external energy 318 directed at one of the peripheral components136.

In some embodiments, the base power of the optic portion 102 can beconfigured to change between about 0.05 diopter (D) to about 0.5 D ineither a positive or negative direction in response to pulses of theexternal energy 318 directed at one of the peripheral components 136.For example, the base power of the optic portion 102 can be configuredto change by about 0.1 D in response to pulses of the external energy318 directed at one of the peripheral components 136.

The change in the base power of the optic portion 102 can be apersistent or a substantially permanent change. A persistent orsubstantially permanent change can mean that the peripheral component136 does not substantially revert back to its original shape or sizeafter the change has occurred.

In certain embodiments, the base power of the optic portion 102 can beconfigured to change in total between about 1.0 D and about 2.0 D ineither a positive or negative direction. In these embodiments, the totalpower change can be dictated by the total number of peripheralcomponents 136, the size and/or expandable characteristics of theperipheral components 136, the chamber volume of the peripheral fluidchamber 108 and/or the optic fluid chamber 106, the volume of the oilwithin such chambers, or a combination thereof.

In other embodiments, the base power of the optic portion 102 can beconfigured to change in total between about 2.0 D and about 3.0 D ineither a positive or negative direction. In additional embodiments, thebase power of the optic portion 102 can be configured to change in totalbetween about 3.0 D and about 5.0 D in either a positive or negativedirection. In further embodiments, the base power of the optic portion102 can be configured to change in total between about 5.0 D and about10.0 D in either a positive or negative direction.

In some embodiments, the optic portion 102 can have an unfilled oras-manufactured optical power (i.e., an optical power of the opticportion 102 when the optic fluid chamber 106 is empty or unfilled) ofbetween about 11 D and 13 D (a “zero power” lens). For example, theoptic portion 102 can have an unfilled or as-manufactured optical powerof about 12 D. The optical power of the optic portion 102 can increaseas the optic fluid chamber 106 is filled with the fluid (e.g., thesilicone oil).

The optic fluid chamber 106 can be filled until the base power of thefilled optic portion 102 (as contributed by both the fluid and the lenssurfaces of the optic portion 102) is between about 15 D (a low-poweredIOL) to about 30 D (a high-powered IOL). For example, the optic fluidchamber 106 can be filled until the base power of the filled opticportion 102 is about 20 D.

The adjustable IOL 100 implanted within a capsular bag of the subjectcan have a base power between about 15 D to about 30 D (e.g., about 20D). A clinician or medical professional can direct the external energy318 (e.g., a laser light) at the peripheral components 136 to increaseor decrease the base power of the optic portion 102 when the adjustableIOL 100 is implanted within the capsular bag of the subject.

For example, the adjustable IOL 100 can have a base power of about 20 Dwhen implanted within the eye of the subject. If power correction isdesired to increase the power of the lens, a clinician or medicalprofessional can direct the external energy 318 at each of the firstperipheral components 138 to increase the base power of the opticportion 102 stepwise between about +0.1 D and +0.2 D until the finalbase power is between about 21 D (+1.0 D change in total) and 22 D (+2.0D change in total).

In other embodiments, the clinician or medical professional can directthe external energy 318 at each of the first peripheral components 138to increase the base power of the optic portion 102 stepwise betweenabout +0.1 D and +0.2 D until the final base power is between about 22 D(+2.0 D change in total) and 25 D (+5.0 D change in total).

As another example, the adjustable IOL 100 can have a base power ofabout 25 D when implanted within the eye of the subject. If powercorrection is desired to decrease the power of the lens, a clinician ormedical professional can direct the external energy 318 at each of thesecond peripheral components 140 to decrease the base power of the opticportion 102 stepwise between about −0.1 D and −0.2 D until the finalbase power is between about 24 D (−1.0 D change in total) and 23 D (−2.0D change in total).

In other embodiments, the clinician or medical professional can directthe external energy 318 at each of the second peripheral components 140to decrease the base power of the optic portion 102 stepwise betweenabout −0.1 D and −0.2 D until the final base power is between about 23 D(−2.0 D change in total) and 20 D (−5.0 D change in total).

In some embodiments, the adjustable IOL 100 can have an opticsensitivity of between about 100 nL to 200 nL (e.g., about 150 nL) offluid displacement per diopter. That is, the base power of the opticportion 102 can change by about 1.0 D when between about 100 nL to 200nL (e.g., about 150 nL) of the fluid is displaced between the peripheralfluid chamber 108 and the optic fluid chamber 106. As a more specificexample, the base power of the optic portion 102 can increase by +1 Dwhen between about 100 nL to 200 nL (e.g., about 150 nL) of the fluidenters the optic fluid chamber 106 from the peripheral fluid chamber 108as a result of the external energy 318 directed at the first peripheralcomponents 138. Moreover, the base power of the optic portion 102 candecrease by −1.0 D when between about 100 nL to 200 nL (e.g., about 150nL) of the fluid exits or is drawn out of the optic fluid chamber 106into the peripheral fluid chamber 108 as a result of the external energy318 directed at the second peripheral components 140.

In certain embodiments, each of the peripheral fluid chambers 108 cancomprise ten first peripheral components 138 and ten second peripheralcomponents 140. In these embodiments, directing the external energy 318at each of the first peripheral components 138 or each of the secondperipheral components 140 can cause between about 10 nL and 20 nL (e.g.,about 15 nL) of the fluid to be displaced or exchanged between the opticfluid chamber 106 and the peripheral fluid chamber 108. For example,directing the external energy 318 at one of the first peripheralcomponents 138 can cause the first peripheral component 138 to expandand decrease the volume of the peripheral fluid chamber 108 housing thefirst peripheral component 138. This can cause between about 10 nL andabout 20 nL (e.g., about 15 nL) of the fluid to flow from the peripheralfluid chamber 108 into the optic fluid chamber 106. Also, for example,directing the external energy 318 at one of the second peripheralcomponents 140 can cause the second peripheral component 140 to expandand increase the volume of the peripheral fluid chamber 108 housing thesecond peripheral component 140. This can cause between about 10 nL andabout 20 nL (e.g., about 15 nL) of the fluid to be drawn out of theoptic fluid chamber 106 into the peripheral fluid chamber 108.

The adjustable IOL 100 can be configured such that the base power of theoptic portion 102 changes between about 0.05 D and 0.5 D as a result ofthis fluid exchange or displacement. As a more specific example, thebase power of the optic portion 102 can change by about 0.1 D inresponse to about 15 nL of the fluid being displaced or exchangedbetween the optic fluid chamber 106 and the peripheral fluid chamber108.

FIG. 3A illustrates a sectional view of the adjustable IOL 100 takenalong cross-section A-A of FIG. 2A. The optic portion 102 can comprisean anterior element 200 and a posterior element 300. A fluid-filledoptic fluid chamber 106 can be defined in between the anterior element200 and the posterior element 300.

The anterior element 200 can comprise an anterior optical surface and ananterior inner surface opposite the anterior optical surface. Theposterior element 300 can comprise a posterior optical surface and aposterior inner surface opposite the posterior optical surface. Any ofthe anterior optical surface, the posterior optical surface, or acombination thereof can be considered and referred to as an externaloptical surface. The anterior inner surface and the posterior innersurface can face the optic fluid chamber 106. At least part of theanterior inner surface and at least part of the posterior inner surfacecan serve as chamber walls of the optic fluid chamber 106. In someembodiments, the peripheral portion 103 (e.g., the haptics 104) can beconnected to or can extend from at least part of the posterior element300 of the optic portion 102.

As will be discussed in more detail in the following sections, theadjustable IOL 100 can have a lens surface profile or pattern (e.g., alight-splitting lens profile or pattern) defined on the external opticalsurface. For example, the lens surface profile can comprise adiffractive surface profile or pattern or a phase-shifting structure orprofile. The lens surface profile or pattern can allow the adjustableIOL 100 to be adapted for different use cases such as providing focusfor one particular distance (monofocal) or focus for multiple distances(multifocal). For example, depending on the lens surface profile orpattern defined on the external optical surface, the adjustable IOL 100can be configured as an adjustable monofocal IOL, an adjustablemultifocal IOL (e.g., an adjustable bifocal or trifocal IOL), or anadjustable extended depth of focus (EDOF) IOL.

The optic portion 102 can be configured to deform, flex, or otherwisechange shape in response to fluid entering or exiting the optic fluidchamber 106. In some embodiments, the anterior element 200 can beconfigured to deform, flex, or otherwise change shape (e.g., change itscurvature) in response to fluid entering or exiting the optic fluidchamber 106. In other embodiments, the posterior element 300 can beconfigured to deform, flex, or otherwise change shape (e.g., change itscurvature) in response to fluid entering or exiting the optic fluidchamber 106. In further embodiments, both the anterior element 200 andthe posterior element 300 can be configured to deform, flex, orotherwise change their shape(s) in response to fluid entering or exitingthe optic fluid chamber 106. The base power of the optic portion 102 canbe configured to change in response to the shape change undertaken bythe shape-changing components of the optic portion 102 (e.g., theanterior element 200, the posterior element 300, or a combinationthereof).

The optic portion 102 can be made in part of a deformable or flexiblematerial. In some embodiments, the optic portion 102 can be made in partof a deformable or flexible polymeric material. For example, theanterior element 200, the posterior element 300 or a combination thereofcan be made in part of a deformable or flexible polymeric material. Atleast part of the peripheral portion 103, such as the one or morehaptics 104 (e.g., the first haptic 104A, the second haptic 104B, or acombination thereof) can be made of the same deformable or flexiblematerial as the optic portion 102. In other embodiments, the one or morehaptics 104 can be made in part of different materials from the opticportion 102.

In some embodiments, the optic portion 102 and the parts of theperipheral portion 103 not made of the composite material 400 cancomprise or be made in part of a polymer or a cross-linked copolymercomprising a copolymer blend.

For example, in some embodiments, the copolymer blend can comprise analkyl acrylate or methacrylate, a fluoro-alkyl (meth)acrylate, aphenyl-alkyl acrylate, or a combination thereof. It is contemplated bythis disclosure and it should be understood by one of ordinary skill inthe art that these types of acrylic cross-linked copolymers can begenerally copolymers of a plurality of acrylates or methacrylates. Theterm “acrylate” as used herein can be understood to mean acrylates ormethacrylates unless otherwise specified.

For example, the optic portion 102 and the parts of the peripheralportion 103 not made of the composite material 400 can be made ofhydrophobic acrylic materials. For example, the hydrophobic acrylicmaterials may comprise a hydrophobic acrylate/methacrylate copolymer. Insome embodiments, the hydrophobic acrylic materials can comprise acombination of phenylethyl acrylate (PEA) and phenylethyl methacrylate(PEMA).

In one example embodiment, the cross-linked copolymer can comprise analkyl acrylate in the amount of about 3% to 20% (wt %), a fluoro-alkylacrylate in the amount of about 10% to 35% (wt %), and a phenyl-alkylacrylate in the amount of about 50% to 80% (wt %). In some embodiments,the cross-linked copolymer can comprise or be made in part of an n-butylacrylate as the alkyl acrylate, trifluoroethyl methacrylate as thefluoro-alkyl acrylate, and phenylethyl acrylate as the phenyl-alkylacrylate. More specifically, the cross-linked copolymer can comprisen-butyl acrylate in the amount of about 3% to 20% (wt %) (e.g., betweenabout 12% to 16%), trifluoroethyl methacrylate in the amount of about10% to 35% (wt %) (e.g., between about 17% to 21%), and phenylethylacrylate in the amount of about 50% to 80% (wt %) (e.g., between about64% to 67%).

The final composition of the cross-linked copolymer can also comprise across-linker or cross-linking agent such as ethylene glycoldimethacrylate (EGDMA). For example, the final composition of thecross-linked copolymer can also comprise a cross-linker or cross-linkingagent (e.g., EGDMA). The final composition of the cross-linked copolymercan also comprise an initiator or initiating agent (e.g., Perkadox 16,camphorquinone, 1-phenyl-1,2-propanedione, and2-ethylhexyl-4-(dimenthylamino)benzoate)) and a UV absorber.

In some embodiments, the refractive index of the material used to makethe optic portion 102 can be between about 1.48 and about 1.53. Incertain embodiments, the refractive index of the material used to makethe optic portion 102 can be between about 1.50 and about 1.53.

In some embodiments, the optic portion 102 and the parts of theperipheral portion 103 not made of the composite material 400 cancomprise a a reactive (polymerizable) UV absorber and a reactiveblue-light absorber. For example, the reactive UV absorber can be orcomprise 2-(2′-hydroxy-3′-methallyl-5′-methylphenyl)benzotriazole,commercially available as o-Methallyl Tinuvin P (“oMTP”) fromPolysciences, Inc., Warrington, Pa.,3-(2H-benzo[d][1,2,3]triazol-2-yl)-4-hydroxyphenylethyl methacrylate,and2-(3-(tert-butyl)-4-hydroxy-5-(5-methoxy-2H-benzo[d][1,2,3]triazol-2-yl)phenoxy)ethylmethacrylate. In certain embodiments, the reactive UV absorbers arepresent in an amount from about 0.1%-5% (wt %). When present, thereactive UV absorbers are typically present in an amount from about1.5%-2.5% (wt %) or in an amount from about 1.5%-2% (wt %).

In certain embodiments, the reactive blue-light absorbing compounds canbe those described in U.S. Pat. Nos. 5,470,932; 8,207,244; and8,329,775, the entire contents of which are hereby incorporated byreference. For example, the blue-light absorbing dye can beN-2-[3-(2′-methylphenylazo)-4-hydroxyphenyl]ethyl methacrylamide. Whenpresent, blue-light absorbers are typically present in an amount fromabout 0.005%-1% (wt %) or in an amount from about 0.01%-0.1% (wt %).

FIG. 3B illustrates a sectional view of the adjustable IOL taken alongcross-section B-B of FIG. 2A. As shown in FIG. 3B, the peripheral fluidchamber 108 can have a chamber height 302. In some embodiments, thechamber height 302 can be about 0.1 mm. In other embodiments, thechamber height 302 can be between about 0.1 mm and 0.3 mm.

In other embodiments, the chamber height 302 can be between about 0.3 mmand 1.0 mm. In further embodiments, the chamber height 302 can bebetween about 1.0 mm and 1.5 mm.

FIG. 3B also illustrates that the lateral side 111 of the optic portion102 can have a side height 304 (as measured in the anterior-to-posteriordirection). In some embodiments, the side height 304 can be betweenabout 0.50 mm and 0.75 mm. For example, the side height 304 can be about0.65 mm. In other embodiments, the side height 304 can be between about0.40 mm and 0.50 mm or between about 0.75 mm and 1.25 mm.

The peripheral portion 103 can also have a peripheral portion height 306(also referred to as haptic height or thickness). In some embodiments,the peripheral portion height 306 can be between about 0.50 mm and 0.60mm. In other embodiments, the peripheral portion height 306 can bebetween about 0.60 mm and 0.65 mm or between about 0.45 mm and 0.50 mm.

As shown in FIG. 3B, the side height 304 of the lateral side 111 of theoptic portion 102 can be greater than the peripheral portion height 306.For example, when the peripheral portion 103 comprises one or morehaptics, the thickness or height of the haptics (as measured in ananterior-to-posterior direction) can be less than the thickness orheight of the optic portion 102 along all sections of the optic portion102.

In some embodiments, the peripheral portion height 306 or thickness (inan anterior-to-posterior direction) can be substantially uniform suchthat no part of the peripheral portion 103 is taller or thicker than anyother part of the peripheral portion 103. When the peripheral portion103 comprises multiple haptics 104, all of the haptics 104 can have thesame height or thickness.

FIG. 3B also illustrates that the anterior element 200 can have ananterior element thickness 308 (as measured in the anterior-to-posteriordirection). In some embodiments, the anterior element thickness 308 canbe between about 0.15 mm and about 0.25 mm. For example, the anteriorelement thickness 308 can be about 0.20 mm.

FIGS. 3A and 3B also illustrate that the first peripheral component 138can be configured as a space-filler 310. The space-filler 310 can beconfigured to expand in response to the external energy 318 directed atthe space-filler 310. Expansion of the space-filler 310 can decrease avolume of the peripheral fluid chamber 108.

As a more specific example, the space-filler 310 can be implemented asan expandable pad extending from at least one of a chamber anterior wall314 and a chamber posterior wall 316. The base power of the opticportion 102 can be configured to increase in response to the externalenergy 318 directed at the space-filler 310, resulting in fluid beingdisplaced out of the peripheral fluid chamber 108 due to the increasedvolume of the space filler 310.

FIG. 3B also illustrates that the second peripheral component 140 can beconfigured as a chamber expander 312. The chamber expander 312 can beconfigured to expand in response to the external energy 318 directed atthe chamber expander 312. Expansion of the chamber expander 312 canincrease a volume of the peripheral fluid chamber 108.

As a more specific example, the chamber expander 312 can be implementedas an expandable column extending from the chamber anterior wall 314 tothe chamber posterior wall 316. Expansion of the expandable column canincrease the volume of the peripheral fluid chamber 108. The base powerof the optic portion 102 can be configured to decrease in response tothe external energy 318 directed at the expandable column, resulting inan expansion of the chamber expander 312 and an increase in the volumeof the peripheral fluid chamber 108.

FIG. 3C illustrates that an external energy 318 can be directed at aspace-filler 310 of the adjustable IOL 100 to induce a shape change inthe space-filler 310.

The first peripheral component 138 can be made of the composite material400. The first peripheral component 138 can be positioned within theperipheral fluid chamber 108.

In some embodiments, the composite material 400 used to make the firstperipheral component 138 can be cured within the peripheral fluidchamber 108 along with the rest of the material used to construct theperipheral fluid chamber 108. In these embodiments, the first peripheralcomponent 138 can be cured in place within the peripheral fluid chamber108.

In other embodiments, the first peripheral component 138 can be adheredto an interior wall or surface of the peripheral fluid chamber 108 usingan adhesive. The adhesive can be cured to secure the first peripheralcomponent 138 to the interior wall or surface of the peripheral fluidchamber 108.

The first peripheral component 138 can be configured as a space-filler310. In some embodiments, the space-filler 310 can be implemented as anexpandable disk-shaped pad (see, e.g., FIGS. 2B, 3A, and 3B). Althoughthe figures illustrate the space-fillers 310 shaped as substantiallyflat cylinders or disks, it is contemplated by this disclosure that thespace-fillers 310 can be substantially shaped as spheres, hemispheres,ovoids, ellipsoids, cuboids or other polyhedrons, or a combinationthereof.

The space-fillers 310 can extend from, be adhered to, or otherwise becoupled to either a chamber anterior wall 314 or a chamber posteriorwall 316. In some embodiments, when the peripheral fluid chamber 108comprises multiple space-fillers 310, at least one of the space-fillers310 can extend from, be adhered to, or otherwise be coupled to thechamber anterior wall 314 and another of the space-fillers 310 canextend from, be adhered to, or otherwise be coupled to the chamberposterior wall 316.

In other embodiments, the space-fillers 310 can extend from, be adheredto, or otherwise be coupled to a chamber interior lateral wall 320.

As shown in FIG. 3C, the space-filler 310 can expand in response to aburst of the external energy 318 directed at the space-filler 310.Expansion of the space-filler 310 can decrease an internal volume of theperipheral fluid chamber 108 and displace fluid from the peripheralfluid chamber 108 into the optic fluid chamber 106. The base power ofthe optic portion 102 can be configured to increase in response to theexternal energy 318 directed at the space-filler 310.

FIG. 3C illustrates that the space-filler 310 can be sized such that thespace-filler 310 does not come into contact with the chamber interiorlateral walls 320. FIG. 3C also illustrates that a separation distance322 or gap can be maintained between the space-filler 310 and each ofthe chamber interior lateral walls 320 even when the space-filler 310 isenlarged in response to the external energy 318 directed at thespace-filler 310. This ensures that the enlarged space-filler 310 doesnot expand the peripheral fluid chamber 108 or expand the peripheralfluid chamber 108 to an extent that would cancel out the effects of theenlarged space-filler 310 on reducing the volume of the peripheral fluidchamber 108. Moreover, an anterior-to-posterior height of thespace-filler 310 can be significantly less than the chamber height 302such that the enlarged space-filler 310 does not come into contact withthe chamber anterior wall 314.

In some embodiments, the external energy 318 can be light energy. Morespecifically, the external energy 318 can be laser light. The externalenergy 318 can be a burst of laser light.

In certain embodiments, the laser light can have a wavelength betweenabout 488 nm to about 650 nm. For example, the laser light can be greenlaser light. The green laser light can have a wavelength of betweenabout 520 nm to about 570 nm. In one example, embodiment, the externalenergy 318 can be green laser light having a wavelength of about 532 nm.

For example, the laser light can be laser light emitted by an ophthalmiclaser. For example, the laser light can be laser light emitted by aretinal coagulation laser.

In certain embodiments, the laser light can be emitted by aneodymium-doped yttrium aluminum garnet (Nd:YAG) laser. As a morespecific example, the laser light can be a pulsed Nd:YAG laser operatingin a Q-switching mode and frequency doubled to generate laser light at532 nm.

In other embodiments, the laser light can be emitted by a femtosecondlaser or an infrared or near infrared laser. For example, the laserlight emitted by such lasers can have a wavelength of between about 1030nm and 1064 nm.

As will be discussed in more detail in the following sections, when theexternal energy 318 is light energy, energy absorbing constituents 404(see FIG. 4A) within the composite material 400 can absorb or otherwisecapture the light energy and convert the light energy into thermalenergy and transfer the thermal energy to expandable components 406 (seeFIGS. 4A and 4B) within the composite material 400 to expand theexpandable components 406.

As previously discussed, in some embodiments about 15 nL of the fluidcan flow from the peripheral fluid chamber 108 into the optic fluidchamber 106 (through the fluid channel 110) in response to expansion ofone of the space-fillers 310. In these and other embodiments, the basepower of the optic portion 102 can be configured to change by about +0.1D in response to pulses of the external energy 318 directed at one ofthe space-fillers 310.

FIG. 3D illustrates that an external energy 318 can be directed at asecond peripheral component 140 of the adjustable IOL 100 to induce ashape change in the second peripheral component 140.

The second peripheral component 140 can be made of the compositematerial 400. The second peripheral component 140 can be positionedwithin the peripheral fluid chamber 108.

In some embodiments, the composite material 400 used to make the secondperipheral component 140 can be cured within the peripheral fluidchamber 108 along with the rest of the material used to construct theperipheral fluid chamber 108. In these embodiments, the secondperipheral component 140 can be cured in place within the peripheralfluid chamber 108.

In other embodiments, the second peripheral component 140 can be adheredto the interior walls or surfaces of the peripheral fluid chamber 108using an adhesive. The adhesive can be cured to secure the secondperipheral component 140 to the interior walls or surfaces of theperipheral fluid chamber 108.

The second peripheral component 140 can be configured as a chamberexpander 312. In some embodiments, the chamber expander 312 can beimplemented as an expandable column extending from the chamber anteriorwall 314 to the chamber posterior wall 316 (see, e.g., FIG. 3B).Although the figures illustrate the chamber expanders 312 shaped assubstantially elongate cylinders, it is contemplated by this disclosurethat the chamber expanders 312 can be substantially shaped as elongateovoids, elongate ellipsoids, elongate cuboids or other polyhedrons,conics, frustoconics, or a combination thereof.

As a more specific example, the chamber expander 312 can be implementedas an expandable column extending from the chamber anterior wall 314 tothe chamber posterior wall 316. Expansion of the expandable column canincrease the volume of the peripheral fluid chamber 108 by pushing onone or both of the chamber interior wall 314 and chamber posterior wall316 to increase the chamber height 302. The base power of the opticportion 102 can be configured to decrease in response to the externalenergy 318 directed at the expandable column.

As shown in FIG. 3D, the chamber expander 312 can expand in response toa burst of the external energy 318 directed at the chamber expander 312.Expansion of the chamber expander 312 can increase a volume of theperipheral fluid chamber 108 and draw fluid from the optic fluid chamber106 into the peripheral fluid chamber 108. The base power of the opticportion 102 can be configured to decrease in response to the externalenergy 318 directed at the chamber expander 312.

The external energy 318 can be the same external energy 318 aspreviously disclosed. For example, the external energy 318 can be lightenergy.

FIG. 3D illustrates that the chamber expander 312 can be sized such thatthe chamber expander 312 does not come into contact with the chamberinterior lateral walls 320 (even when expanded). This ensures that theenlarged chamber expander 312 expands the peripheral fluid chamber 108primarily in an anterior-to-posterior direction and does not putpressure on the radially inner chamber wall 132 (which could thentranslate into pressure applied to the lateral sides of the opticportion 102, thereby inadvertently affecting the optical power).

As previously discussed, in some embodiments about 15 nL of the fluidcan flow from the optic fluid chamber 106 into the peripheral fluidchamber 108 (through the fluid channel 110) in response to pulses of theexternal energy 318 directed at one of the chamber expanders 312. Inthese and other embodiments, the base power of the optic portion 102 canbe configured to change by about −0.1 D in response to an expansion ofone of the chamber expanders 312 caused by the external energy 318directed at the chamber expander 312.

Although FIGS. 1A, 1B, 2B, and 5 illustrate each of the peripheral fluidchambers 108 (e.g., each of the haptic fluid chambers) comprising boththe space-fillers 310 and the chamber expanders 312, it is contemplatedby this disclosure and it should be understood by one of ordinary skillin the art that each of the peripheral fluid chambers 108 can alsocomprise only the space-fillers 310 or only the chamber expanders 312.

One technical problem faced by the applicants is how to provide aclinician or other medical professional the ability to fine tune theoptical power of an implanted IOL in both directions (i.e., providingthe clinician the ability to increase or decrease the optical power ofthe implanted IOL post-operatively). One solution discovered by theapplicants are the peripheral components disclosed herein including, forexample, the space-fillers and chamber expanders made of the compositematerial. As a more specific example, each peripheral fluid chamber (orhaptic fluid chamber) can comprise a plurality of the space-fillers, thechamber expanders, or both the space-fillers and chamber expanders. Eachperipheral component can be configured to cause the optic portion of theadjustable IOL to change by about 0.1 D in response to a burst of anexternal energy directed at the peripheral component.

FIG. 4A is a graphic representation of a composite material 400comprising a composite base material 402, an energy absorbingconstituent 404, and a plurality of expandable components 406. Aspreviously discussed, at least part of the peripheral portion 103 orcomponents within the peripheral portion 103 can be made of thecomposite material 400.

The composite base material 402 can be comprised of hydrophobic acrylicmaterials. For example, the composite base material 402 can be comprisedof phenylethyl acrylate (PEA), a phenylethyl methacrylate (PEMA), or acombination thereof.

In one example embodiment, the composite base material 402 can comprisea methacrylate-functional or methacrylic-functional cross-linkablepolymer and reactive acrylic monomer diluents including laurylmethacrylate (n-dodecyl methacrylate or SR313) and ADMA. By controllingthe amount of lauryl methacrylate (SR313) to ADMA, the overallcorresponding hardness (i.e., more ADMA) or softness (i.e., more SR313)of the cured composite material 400 can be controlled. Themethacrylate-functional or methacrylic-functional cross-linkable polymercan be made using the cross-linkable polymer precursor formulation.

The cross-linkable polymer precursor formulation can comprise the samecopolymer blend used to make the optic portion and the haptics.

The copolymer blend can comprise an alkyl acrylate or methacrylate(e.g., n-butyl acrylate), a fluoro-alkyl (meth)acrylate (e.g.,trifluoroethyl methacrylate), and a phenyl-alkyl acrylate (e.g.,phenylethyl acrylate). For example, the copolymer blend can comprisen-butyl acrylate in the amount of about 41% to about 45% (wt %),trifluoroethyl methacrylate in the amount of about 20% to about 24% (wt%), and phenylethyl acrylate in the amount of about 28% to about 32% (wt%). The cross-linkable polymer precursor formulation can comprise or bemade in part of the copolymer blend, a hydroxyl-functional acrylicmonomer (e.g., HEA), and a photoinitiator (e.g., Darocur 4265 or a 50/50blend of diphenyl(2,4,6-trimethylbenzoyl)-phosphine oxide and2-hydroxy2-methylpropiophenone).

The composite base material 402 can comprise the methacrylate-functionalor methacrylic-functional cross-linkable polymer (as discussed above) inthe amount of about 50% to about 65% (e.g., about 55% to about 60%) (wt%), the reactive acrylic monomer diluent lauryl methacrylate (SR313) inthe amount of about 32% to about 38% (e.g., about 32.70%) (wt %), thereactive acrylic monomer diluent adamantly methacrylate (ADMA) in theamount of about 5% to about 9% (e.g., about 7.30%) (wt %).

Table 1 below provides an example formulation for the composite material400:

TABLE 1 FORMULATION OF COMPOSITE MATERIAL (WT %) Cross-linkable polymer(in two 1.47% 2-hydroxyethyl acrylate (HEA) steps from precursor 1.96%Darocur 4265 (photoinitiator) formulation, as described above) 43.49%n-butylacrylate (nBA) 30.21% 2-phenylethylacrylate (PEA) 22.87%2,2,2-trifluoroethylmethacrylate (TFEMA) Composite base material 60.00%cross-linkable polymer 32.70% lauryl methacrylate (SR313) 7.30%1-adamantyl methacrylate (ADMA) Composite base material with 99.50%composite base material red energy absorbing colorant 0.50% Disperse Red1 dye Composite base material with 99.95% composite base material blackenergy absorbing colorant 0.05% graphitized mesoporous carbon blackFinal formulation of 87.70% composite base material with red or blackenergy composite material absorbing colorant 10.00% expandablemicrospheres 1.00% Luperox peroxide (thermal initiator) 1.30% Omnirad2022

The composite material 400 can be made in several operations. The firstoperation can comprise preparing an uncolored composite base material402. The second operation can comprise mixing the composite basematerial 402 with an energy absorbing constituent 404, expandablecomponents 406, and initiators such as one or more photoinitiators,thermal initiators, or a combination thereof. The third operation cancomprise placing the uncured composite material 400 into a desiredlocation within the peripheral portion 103 (e.g., the peripheral fluidchambers 108 and/or the haptic(s) 104), and curing the compositematerial 400 in place.

For example, the uncolored composite base material 402 can be mixed withan energy absorbing constituent 404 such as a dye (e.g., Disperse Red 1dye) or pigment (graphitized carbon black). The energy absorbingconstituent 404 will be discussed in more detail below.

In some embodiments, the expandable components 406 can make up about5.0% to about 15.0% by weight of a final formulation of the compositematerial 400. More specifically, the expandable components 406 can makeup about 8.0% to about 12.0% (e.g., about 10.0%) by weight of a finalformulation (see Table 1) of the composite material 400. In these andother embodiments, the energy absorbing constituent 404 can make upabout 0.044% to about 0.44% (or about 0.55%) by weight of the finalformulation of the composite material 400.

The photoinitiator can be Omnirad 2022(bis(2,4,6-trimethylbenzoyl)phenyl-phosphineoxide/2-hydroxy-2-methyl-1-phenyl-propan-1-one).The photoinitiator can make up about 1.30% by weight of a finalformulation of the composite material 400 (see, e.g., Table 1). Inaddition, the composite material 400 can also comprise a thermalinitiator. The thermal initiator can make up about 1.00% by weight of afinal formulation of the composite material 400 (see, e.g., Table 1). Insome embodiments, the thermal initiator can be a dialkyl peroxide suchas Luperox® peroxide. In other embodiments, the thermal initiator can bePerkadox.

In some embodiments, the energy absorbing constituent (e.g., dye orpigment) can be positioned or located adjacent to the uncoloredcomposite base material 402. In this embodiment, the energy absorbingconstituent 404 can absorb the external energy 318 (e.g., laser energy),convert the energy to heat, and conduct the energy to the composite basematerial 402 to expand the composite base material 402. One addedbenefit of this approach is that the energy absorbing constituent 404can be made more discrete and an easier target for a clinician orsurgeon to hit with a laser or other external energy 318.

FIG. 4B illustrates that the expandable components 406 can be expandablemicrospheres comprising an expandable thermoplastic shell 408 and ablowing agent 410 contained within the expandable thermoplastic shell408. The microspheres can be configured to expand such that a diameter412 of at least one of the microspheres can increase about 2× theoriginal diameter. In other embodiments, the microspheres can beconfigured to expand such that the diameter 412 of at least one of themicrospheres can increase about 4× or four times the original diameter.In further embodiments, the microspheres can be configured to expandsuch that the diameter 412 of at least one of the microspheres canincrease between about 2× and about 4× (or about 3.5×) the originaldiameter. For example, the microspheres can have a diameter 412 of about12 μm at the outset. In response to an external energy applied ordirected at the composite material 400 or in response to energytransferred or transmitted to the microspheres, the diameter 412 of themicrospheres can increase to about 40 μm.

The volume of at least one of the microspheres can be configured toexpand between about ten times (10×) to about 50 times (50×) in responseto the external energy applied or directed at the composite material 400or in response to energy transferred or transmitted to the microspheres.

In some embodiments, the blowing agent 410 can be an expandable fluid,such as an expandable gas. More specifically, the blowing agent 410 canbe a branched-chain hydrocarbon. For example, the blowing agent 410 canbe isopentane. In other embodiments, the blowing agent 410 can be orcomprise cyclopentane, pentane, or a mixture of cyclopentane, pentane,and isopentane.

The expandable components 406 can comprise differing amounts of theblowing agent 410. For example, some expandable components 406 cancomprise more or a greater amount of the blowing agent (e.g., moreexpandable gas) to allow such expandable components 406 to expand more,resulting in greater expansion of the composite material 400 comprisingsuch expandable components 406.

FIG. 4B illustrates that each of the expandable components 406 cancomprise a thermoplastic shell 408. FIG. 4B also illustrates that athickness of the thermoplastic shell 408 can change as the expandablecomponent 406 increases in size. More specifically, the thickness of thethermoplastic shell 408 can decrease as the expandable component 406increases in size. For example, when the expandable components 406 areexpandable microspheres, the thickness of the thermoplastic shell 408(i.e., its thickness in a radial direction) can decrease as the diameter412 of the expandable microsphere increases.

For example, as previously discussed, at least one of the expandablemicrospheres can have a diameter 412 of about 12 μm at the outset. Inthis embodiment, the thermoplastic shell 408 of the expandablemicrosphere can have a shell thickness of about 2.0 μm. In response toan external energy applied or directed at the composite material 400 orin response to energy transferred or transmitted to the microsphere, thediameter 412 of the microsphere can increase to about 40 μm (and thevolume expand between about 10× and 50×) and the shell thickness of themicrosphere can decrease to about 0.1 μm.

Although FIGS. 4A and 4B illustrate the expandable components 406 asspheres or microspheres, it is contemplated by this disclosure that theexpandable components 406 can be substantially shaped as ovoids,ellipsoids, cuboids or other polyhedrons, or a combination thereof.

In some embodiments, the thermoplastic shell 408 can be made in part ofnitriles or acrylonitrile copolymers. For example, the thermoplasticshell 408 can be made in part of acrylonitrile, styrene, butadiene,methyl acrylate, or a combination thereof.

As previously discussed, the expandable components 406 can make upbetween about 8.0% to about 12% by weight of a final formulation of thecomposite material 400. The expandable components 406 can make up about10% by weight of a final formulation of the composite material 400.

The expandable components 406 can be dispersed or otherwise distributedwithin the composite base material 402 making up the bulk of thecomposite material 400. The composite base material 402 can serve as amatrix for holding or carrying the expandable components 406. Thecomposite material 400 can expand in response to an expansion of theexpandable components 406 (e.g., the thermoplastic microspheres). Forexample, a volume of the composite material 400 can increase in responseto the expansion of the expandable components 406.

The composite material 400 also comprises an energy absorbingconstituent 404. In some embodiments, the energy absorbing constituent404 can be an energy absorbing colorant.

In certain embodiments, the energy absorbing colorant can be an energyabsorbing dye. For example, the energy absorbing dye can be an azo dye.In some embodiments, the azo dye can be a red azo dye such as DisperseRed 1 dye. In other embodiments, the azo dye can be an orange azo dyesuch as Disperse Orange dye (e.g., Disperse Orange 1), a yellow azo dyesuch as Disperse Yellow dye (e.g., Disperse Yellow 1), a blue azo dyesuch as Disperse Blue dye (e.g., Disperse Blue 1), or a combinationthereof.

In additional embodiments, the energy absorbing colorant can be orcomprise a pigment. For example, the energy absorbing colorant can be orcomprise graphitized carbon black as the pigment.

Similar to the expandable components 406, the energy absorbingconstituent 404 can be dispersed or otherwise distributed within thecomposite base material 402 making up the bulk of the composite material400. The composite base material 402 can serve as a matrix for holdingor carrying the expandable components 406 and the energy absorbingconstituent 404.

As previously discussed, the energy absorbing constituent 404 can makeup between about 0.025% to about 1.0% (or, more specifically, about0.045% to about 0.45%) by weight of a final formulation of the compositematerial 400. For example, when the energy absorbing constituent 404 isa dye (e.g., an azo dye such as Disperse Red 1), the energy absorbingconstituent 404 can make up about between about 0.45% to about 1.0% byweight of a final formulation of the composite material 400. When theenergy absorbing constituent 404 is graphitized carbon black or othertypes of pigments, the energy absorbing constituent 404 can make upabout 0.025% to about 0.045% by weight of a final formulation of thecomposite material 400.

The energy absorbing constituent 404 (e.g., azo dye, graphitized carbonblack, or a combination thereof) can absorb or capture an externalenergy applied or directed at the composite material 400. The energyabsorbing constituent 404 can absorb or capture the external energy andthen transform or transfer the energy into thermal energy or heat to theexpandable components 406.

The thermoplastic shell 408 can soften and begin to flow as thermalenergy is transferred or transmitted to the expandable components 406.The thermoplastic shell 408 of the expandable components 406 can thenbegin to thin or reduce in thickness in response to the thermal energytransferred or transmitted to the expandable components 406. As thethermoplastic shell 408 begins to soften and reduce in thickness, theblowing agent 410 within the expandable components 406 can expand. Theblowing agent 410 can also expand in response to the thermal energy orheat transferred or transmitted to the expandable components 406.Expansion of the blowing agents 410 can cause the expandable components406 (e.g., the thermoplastic microspheres) to expand or increase involume. This ultimately causes the composite material 400 to expand orincrease in volume.

The composite material 400 can expand or increase in size in anisotropic manner such that the composite material 400 expands in alldirections. Such isotropic expansion can be harnessed to produceexpansion or material displacement in specific directions by placing orpositioning the composite material 400 at specific locations within theperipheral fluid chambers 108 along the haptic(s) 104 or optic portion102 of the adjustable IOL 100.

As will be discussed in more detail in the following sections, in someembodiments, the external energy can be light energy and the energyabsorbing constituent 404 can absorb or capture the light energydirected at the composite material 400 and transform or transfer thelight energy into thermal energy or heat to the expandable components406. The blowing agent 410 within the expandable components 406 canexpand or become energized in response to the thermal energy or heat.The expandable components 406 and, ultimately, the composite material400 can expand or increase in volume in response to this light energydirected at the composite material 400.

The shape change (e.g., increase in volume) undertaken by the expandablecomponents 406 can be a persistent or a substantially permanent change.A persistent or substantially permanent change can mean that theexpandable components 406 do not substantially revert back to itsoriginal shape or size after the shape change (e.g., after an increasein volume) has occurred. As a result, any change in the size or volumeof the composite material 400 caused by a change in the size or volumeof the expandable components 406 is also persistent or substantiallypermanent. As will be discussed in more detail in the followingsections, this means that any structural changes made to the adjustableIOL 100 as a result of external energy or stimulus applied or otherwisedirected at the composite material 400 embedded or integrated within theadjustable IOL 100 can persist or remain substantially permanent.

The thermoplastic shells 408 of the expandable components 406 canharden, once again, when the external energy is no longer directed orapplied to the composite material 400. For example, the thermoplasticshells 408 may again harden when the temperature within a vicinity ofthe expandable components 406 falls below a certain threshold. Forexample, the thermoplastic shells 408 of the expandable microspheres canharden when light energy is no longer directed at the composite material400. After the thermoplastic shells 408 harden, the expandablecomponents 406 are locked into their new size and expandedconfiguration.

When the energy absorbing constituent 404 is an energy absorbingcolorant, such as a dye or graphitized carbon, the color of at leastpart of the composite material 400 can take on the color of the energyabsorbing colorant. For example, when the energy absorbing constituent404 is an azo dye such as Disperse Red 1 having a red color, at least aportion of the composite material 400 comprising the energy absorbingconstituent 404 can be colored red. Moreover, when the energy absorbingconstituent 404 is graphitized carbon having a black color, at least aportion of the composite material 400 comprising the energy absorbingconstituent 404 can be colored black. Although two colors (e.g., red andblack) are mentioned in this disclosure, it is contemplated by thisdisclosure and it should be understood by one of ordinary skill in theart that energy absorbing colorant of other types of colors can also beused such as energy absorbing yellow, orange, or blue dyes or materials.

The color of the energy absorbing colorant can be visually perceptibleto a clinician or another medical professional when at least part of theadjustable IOL 100 is made of the composite material 400 comprising theenergy absorbing colorant. The color of the energy absorbing colorantcan be visually perceptible to a clinician or another medicalprofessional when the adjustable IOL 100 is implanted within an eye of apatient. For example, the composite material 400 can comprise DisperseRed 1 serving as the energy absorbing colorant. In this example, atleast part of the adjustable IOL 100 can appear red to the clinician oranother medical professional when the adjustable IOL 100 is implantedwithin the eye of a patient.

The color of the energy absorbing colorant can allow the clinician oranother medical professional to detect or determine the location orposition of the composite material 400 within the adjustable IOL 100.The color of the energy absorbing colorant can also allow the clinicianor another medical professional to determine where to direct theexternal energy or stimulus to adjust the adjustable IOL 100.

One technical problem faced by the applicants is how to integrate thecomposite material into the peripheral portion (e.g., the haptics) ofthe adjustable IOL such that the composite material would adhere to thematerial used to make the rest of the adjustable IOL and remainsubstantially fixed at certain locations within the peripheral portion.One solution discovered by the applicants and disclosed herein is theunique composition of the composite material 400 which incorporates thesame copolymer blend used to make the rest of the lens. By designing theadjustable IOL in this manner, the composite material 400 can becompatible with the rest of the material used to construct theperipheral portion and remains substantially fixed at its locationwithout migrating or shifting.

Another technical problem faced by the applicants is how to ensure thatany adjustments made to the adjustable IOL persist long after theadjustment procedure. One solution discovered by the applicants anddisclosed herein is to induce an expansion of a composite material madein part of expandable microspheres comprising a blowing agent containedwithin thermoplastic shells. The thermoplastic shells can soften (andthe thickness of the thermoplastic shells can decrease) in response toan external energy directed or applied at the composite material (whichcan result in heat or thermal energy being transferred or transmitted tothe expandable microspheres). The blowing agent within the thermoplasticshells can expand as the thermoplastic shells soften. Expansion of theblowing agent can expand the microspheres, which can, in turn, expandthe composite base material serving as the bulk of the compositematerial. The expandable microspheres can retain their new enlarged orexpanded configuration even after the external energy is no longerapplied to the composite material.

Moreover, the energy absorbing constituent of the composite material 400can capture or absorb a relatively harmless external energy or stimulusdirected at the composite material and transform or transfer theexternal energy into thermal energy which can then cause thethermoplastic microspheres to expand. By designing the adjustable IOL100 in this manner, a burst of relatively harmless energy or stimulus(e.g., light energy) can be used to induce a persistent change in theshape or size of at least part of the adjustable IOL 100. Thispersistent change in the shape or size of the adjustable IOL 100 canhave a continuing effect on an optical parameter of the lens including,for example, its base power.

FIG. 5 illustrates a top plan view of another embodiment of theadjustable static-focus IOL 100 with part of the anterior portion of theadjustable IOL 100 removed to better illustrate components within theIOL. As shown in FIG. 5 , the first peripheral components 138 can bemade of a first composite material comprising a first energy absorbingconstituent having a first color and the second peripheral components140 can be made of a second composite material comprising a secondenergy absorbing constituent having a second color different from thefirst color. This difference in color can be visually perceptible to aclinician or another medical professional and can allow the clinician orother medical professional to visually differentiate between the twotypes of peripheral components 136.

For example, the first energy absorbing constituent can be an energyabsorbing dye. As a more specific example, the energy absorbing dye canbe an azo dye such as a red azo dye (e.g., Disperse Red 1 dye). In thisexample, the second energy absorbing constituent can be another energyabsorbing dye such as a yellow azo dye or another lighter-colored dye.

In other examples, the first energy absorbing constituent can be orcomprise a pigment such as graphitized carbon black (which exhibits ablack color). In these examples, the second energy absorbing constituentcan be an energy absorbing dye (e.g., a red azo dye).

In additional examples, the second energy absorbing constituent can beor comprise a pigment such as graphitized carbon black (which exhibits ablack color). In these examples, the first energy absorbing constituentcan be an energy absorbing dye (e.g., a red azo dye).

In other embodiments, the first composite material and the secondcomposite material can be made in part of the same energy absorbingconstituents or colorants but comprise different amounts or weightpercentages of such constituents or colorants.

In certain embodiments, the first peripheral component 138 made of thefirst composite material (and having a first color) can expand or changeshape in response to a first type of external energy (e.g., light energybetween 520 nm to 540 nm) directed at the first composite material andthe second peripheral component 140 made of the second compositematerial (and having a second color different from the first color) canexpand in response to a second type of external energy (e.g., lightenergy between 600 nm and 650 nm) directed at the second compositematerial.

By designing the adjustable IOL 100 in this manner, a clinician oranother medical professional can direct external energy or stimulus atdifferent target sites along the peripheral portion 103 using thedifferent colors of the composite materials as guides or markers.Moreover, the different colored composite materials can also serve asindicators or visual cues as to where to direct the external energy orstimulus to cause certain changes in the base power of the optic portion102.

For example, the adjustable IOL 100 can be configured such that a basepower of the adjustable IOL 100 can be adjusted in a first manner (e.g.,the base power can be increased) by directing or otherwise applying anexternal energy at a first peripheral component 138 made of the firstcomposite material (having a first color). The base power of theadjustable IOL 100 can also be adjusted in a second manner (e.g., thebase power can be decreased) by directing or otherwise applyingadditional bursts or pulses of the external energy at a secondperipheral component 140 made of a second composite material (having asecond color different from the first color).

FIG. 6 illustrates a top plan view of another embodiment of theadjustable IOL 100 with an optic portion 102 comprising a lightsplitting lens surface profile 600. The peripheral portion 103 of theadjustable IOL 100 is shown in broken lines to emphasize the opticportion 102.

One technical problem faced by the applicants is how to design afluid-filled IOL that can be used by patients seeking different types ofvision support (e.g., near vision, intermediate vision, distance vision,etc.). One solution discovered by the applicants is the adjustable IOLdisclosed herein where different lens surface profiles, bothrotationally symmetric as well as in toric profiles so as to correct forastigmatism, can be defined on an external optical surface (e.g., ananterior optical surface) of the optic portion allowing for the sameadjustable IOL structure to be adapted as an adjustable monofocal IOL,an adjustable bifocal IOL, an adjustable trifocal IOL, or an adjustableEDOF IOL, in both toric and non-toric shapes.

As shown in FIG. 6 , the optic portion 102 of the adjustable IOL 100 cancomprise a light splitting lens surface profile 600 defined on a lenssurface of the optic portion 102. In some embodiments, the lightsplitting lens surface profile 600 can comprise a central diffractivearea or structure comprising a plurality of diffractive zones or steps.In these and other embodiments, the widths of the diffractive zones candecrease in a radially outward manner such that zone widths at aperiphery of the lens are smaller than zone widths near a centralportion of the lens.

The light splitting lens surface profile 600 can split light intomultiple foci or focal points. In these embodiments, the adjustable IOL100 can be considered an adjustable multifocal IOL or anon-accommodating fluid-adjustable multifocal IOL. Even though the lightsplitting lens surface profile 600 can split light into multiple foci orfocal points, each such focal point is static and the fluid-adjustablemultifocal IOL is considered non-accommodating.

In some embodiments, the light splitting lens surface profile 600 can beconfigured to split light into two focal points (e.g., allowing for nearand distant vision). In these embodiments, the adjustable IOL 100 can beconsidered an adjustable bifocal IOL or a non-accommodatingfluid-adjustable bifocal IOL. In these embodiments, even though thelight splitting lens surface profile 600 can split light into two focalpoints, each such focal point is static and the fluid-adjustable bifocalIOL is considered non-accommodating.

The light splitting lens surface profile 600 can also be configured tosplit light into three focal points (e.g., allowing for near,intermediate, and distant vision). In these embodiments, the adjustableIOL 100 can be considered an adjustable trifocal IOL or anon-accommodating fluid-adjustable trifocal IOL.

In other embodiments not shown in FIG. 6 , the optic portion 102 of theadjustable IOL 100 can have a uniformly curved (e.g., a spherical) lenssurface or an aspherical lens surface providing focusing power for asingle distance. In these embodiments, the adjustable IOL 100 can beconsidered an adjustable monofocal IOL or a non-accommodatingfluid-adjustable monofocal IOL.

In additional embodiments not shown in FIG. 6 , the optic portion 102 ofthe adjustable IOL 100 can have a lens surface profile or patternconfigured to provide an extended depth of focus or a single elongatedfocal point. In these embodiments, the adjustable IOL 100 can beconsidered an adjustable extended depth of focus (EDOF) IOL or anon-accommodating fluid-adjustable EDOF IOL.

It is contemplated by this disclosure that the unique peripheral portion103 disclosed herein can be compatible with optic portions 102comprising a variety of lens surface profiles.

Thus, directing external energy (e.g., laser light) at peripheralcomponent(s) 136 made of the composite material 400 in the peripheralportion 103 can adjust the focusing power(s) or focusing length(s)provided by such lens surface profiles.

Any of the adjustable monofocal IOL, the adjustable multifocal IOL, andthe adjustable EDOF IOL can comprise a toric lens profile.

FIG. 7 is one embodiment of a method 700 of adjusting an IOL 100 postoperatively. The method 700 can comprise increasing a base power of anIOL 100 post-operatively by directing an external energy 318 at acomposite material 400 configured as a space-filler 310 positionedwithin a peripheral fluid chamber 108 defined within a peripheralportion 103 of the IOL 100 in operation 702. The method 700 can alsocomprise decreasing the base power by directing the external energy 318at another instance of the composite material 400 configured as achamber expander 312 positioned within the peripheral fluid chamber 108in operation 704.

FIG. 8 is another embodiment of a method 800 of adjusting an IOL 100post-operatively. The method 800 can comprise adjusting a base power ofthe IOL 100 by directing pulses of an external energy 318 at a firstperipheral component 138 within a peripheral fluid chamber 108 definedwithin a peripheral portion 103 of the IOL 100 in operation 802. Themethod 800 can also comprise further adjusting the base power bydirecting additional pulses of the external energy 318 at a secondperipheral component 140 within the same peripheral fluid chamber 108 inoperation 804.

For example, the first peripheral component 138 can be a space-filler310 and directing the external energy 318 at the space-filler 310 canexpand the space-filler 310 and decrease a volume of the peripheralfluid chamber 108 and displace fluid from the peripheral fluid chamber108 into the optic fluid chamber 106 (thereby increasing the base powerof the optic portion 102). The second peripheral component 140 can be achamber expander 312 and directing the external energy 318 at thechamber expander 312 can expand the chamber expander 312 and increasethe volume of the peripheral fluid chamber 108 and draw fluid from theoptic fluid chamber 106 into the peripheral fluid chamber 108 (therebydecreasing the base power of the optic portion 102).

Alternatively, the external energy 318 can be directed first at thechamber expander 312 to decrease the base power of the optic portion 102and then the external energy 318 can be directed subsequently at thespace-filler 310 to increase the base power of the optic portion 102.

FIG. 9 is yet another embodiment of a method 900 of adjusting an IOL 100post-operatively. The method 900 can comprise adjusting a base power ofthe IOL 100 by directing pulses of an external energy at a firstperipheral component 138 within a first of the peripheral fluid chambers108 (e.g., a first haptic fluid chamber) defined within a peripheralportion 103 of the IOL 100 in operation 902. The method 900 can furthercomprise adjusting the base power of the IOL 100 by directing additionalpulses of the external energy at a second peripheral component 140 oranother instance of the first peripheral component 138 within a secondof the peripheral chambers 108 (e.g., a second haptic fluid chamber) ofthe peripheral portion 103 of the IOL 100 in operation 904.

The first peripheral component 138 can be a space-filler 310 anddirecting the external energy 318 at the space-filler 310 can expand thespace-filler 310 and decrease a volume of the first peripheral fluidchamber and displace fluid from the first peripheral fluid chamber intothe optic fluid chamber 106 (thereby increasing the base power of theoptic portion 102). The second peripheral component 140 can be a chamberexpander 312 and directing the external energy 318 at the chamberexpander 312 can expand the chamber expander 312 and increase the volumeof the second peripheral fluid chamber and draw fluid from the opticfluid chamber 106 into the second peripheral fluid chamber (therebydecreasing the base power of the optic portion 102).

In some embodiments, pulses of the external energy 318 can be directedat a chamber expander 312 within the first peripheral fluid chamber todecrease the base power of the optic portion 102 and additional pulsesof the external energy 318 can be directed at a space-filler 310 withinthe second peripheral fluid chamber to increase the base power of theoptic portion 102.

FIG. 10 is an additional embodiment of a method 1000 of adjusting an IOL100 post-operatively. The method 1000 can comprise adjusting a basepower of the IOL 100 in a first direction by directing an externalenergy 318 at a first composite material in operation 1002. The firstcomposite material can comprise a first energy absorbing constituenthaving a first color. The method 1000 can further comprise adjusting thebase power of the IOL 100 in a second direction by directing theexternal energy at a second composite material in operation 1004. Thesecond composite material can comprise a second energy absorbingconstituent having a second color different from the first color.

For example, the first composite material can be formed as aspace-filler 310. In this example, the first energy absorbingconstituent of the first composite material can be an azo dye having afirst color (e.g., a red color). Also, in this example, the secondcomposite material can be formed as a chamber expander 312 and thesecond energy absorbing constituent of the second composite material canbe an energy absorbing pigment such as graphitized carbon black or anazo dye having a second color different from the first color (e.g., ablue color or yellow color).

In other embodiments, the first composite material can be formed as achamber expander 312 and the first energy absorbing constituent of thefirst composite material can be an azo dye having a first color (e.g., ared color). In these embodiments, the second composite material can beformed as a space-filler 310 and the second energy absorbing constituentof the second composite material can be an energy absorbing pigment suchas graphitized carbon black or an azo dye having a second colordifferent from the first color (e.g., a blue color or yellow color).

In one or more of the methods disclosed herein, adjusting the base powerof the IOL 100 can comprise adjusting the base power of the opticportion 102 by between about ±0.05 D to about ±0.50 D by directingpulses of the external energy 318 at the composite material 400 toexpand the composite material 400. For example, adjusting the base powerof the IOL 100 can comprise adjusting the base power of the opticportion 102 by about ±0.10 D by directing pulses of the external energy318 at the composite material 400 to expand the composite material 400.

For example, the base power of the optic portion 102 can be adjusted bybetween about ±0.05 D to about ±0.50 D in response to fluid displacementor exchange between the optic fluid chamber 106 and one of theperipheral fluid chambers 108 due to a change in the volume of theperipheral fluid chamber 108 as a result of an expansion of a peripheralcomponent 136 caused by pulses of the external energy 318 directed atthe peripheral component 136. As a more specific example, the base powerof the optic portion 102 can increase by between about +0.05 D to about+0.50 D in response to fluid entering the optic fluid chamber 106 fromone of the peripheral fluid chambers 108 due to a reduction in thevolume of the peripheral fluid chamber 108 as a result of an expansionof a first peripheral component 138 caused by pulses of the externalenergy 318 directed at the first peripheral component 138. As anothermore specific example, the base power of the optic portion 102 candecrease by between about −0.05 D to about −0.50 D in response to fluidexiting the optic fluid chamber 106 into one of the peripheral fluidchambers 108 due to an increase in the volume of the peripheral fluidchamber 108 as a result of an expansion of a second peripheral component140 caused by pulses of the external energy 318 directed at the secondperipheral component 140.

In one or more of the methods disclosed herein, adjusting the base powerof the IOL 100 can comprise adjusting the base power of the IOL 100 intotal between about ±1.0 D and about ±2.0 D by directing pulses of theexternal energy 318 at multiple peripheral components 136.

In one or more of the methods disclosed herein, directing the externalenergy 318 at the composite material can further comprise directinglight energy at the composite material 400. For example, directing theexternal energy 318 at the composite material 400 can further comprisedirecting laser light at the composite material 400. As a more specificexample, directing the external energy 318 at the composite material 400can further comprise directing green laser light at the compositematerial 400.

In one or more of the methods disclosed herein, directing the externalenergy 318 at the composite material 400 can comprise directing laserlight having a wavelength between about 488 nm to about 650 nm at thecomposite material 400. In other embodiments, directing the externalenergy 318 at the composite material 400 can further comprise directinglaser light having a wavelength between about 946 nm to about 1120 nm atthe composite material 400.

One drawback of currently available tunable IOLs (such as lightadjustable lens) is that the tuning procedure requires time to takeeffect, may require multiple visits to a clinician's office, and theclinician must often purchase expensive new equipment to undertake suchtuning procedures. One advantage of the static-focus adjustable IOLs 100disclosed herein is that such static-focus adjustable IOLs 100 allow forpost-operative refractive error correction in a matter of seconds ratherthan hours. This allows patients to provide feedback concerning theirrefractive error correction almost instantaneously. Moreover, the IOLs100 disclosed herein can be tuned using commercially available lasers(e.g., 532 nm photocoagulator lasers) that are commonly found in mostclinician's offices. Moreover, patients do not need to wear U.V blockingglasses during the healing period and refractive error correction can beundertaken months or even years after the initial implantationprocedure.

A number of embodiments have been described. Nevertheless, it will beunderstood by one of ordinary skill in the art that various changes andmodifications can be made to this disclosure without departing from thespirit and scope of the embodiments. Elements of systems, devices,apparatus, and methods shown with any embodiment are exemplary for thespecific embodiment and can be used in combination or otherwise on otherembodiments within this disclosure. For example, the steps of anymethods depicted in the figures or described in this disclosure do notrequire the particular order or sequential order shown or described toachieve the desired results. In addition, other steps operations may beprovided, or steps or operations may be eliminated or omitted from thedescribed methods or processes to achieve the desired results. Moreover,any components or parts of any apparatus or systems described in thisdisclosure or depicted in the figures may be removed, eliminated, oromitted to achieve the desired results. In addition, certain componentsor parts of the systems, devices, or apparatus shown or described hereinhave been omitted for the sake of succinctness and clarity.

Accordingly, other embodiments are within the scope of the followingclaims and the specification and/or drawings may be regarded in anillustrative rather than a restrictive sense.

Each of the individual variations or embodiments described andillustrated herein has discrete components and features which may bereadily separated from or combined with the features of any of the othervariations or embodiments. Modifications may be made to adapt aparticular situation, material, composition of matter, process, processact(s) or step(s) to the objective(s), spirit or scope of the presentinvention.

Methods recited herein may be carried out in any order of the recitedevents that is logically possible, as well as the recited order ofevents. Moreover, additional steps or operations may be provided orsteps or operations may be eliminated to achieve the desired result.

Furthermore, where a range of values is provided, every interveningvalue between the upper and lower limit of that range and any otherstated or intervening value in that stated range is encompassed withinthe invention. Also, any optional feature of the inventive variationsdescribed may be set forth and claimed independently, or in combinationwith any one or more of the features described herein. For example, adescription of a range from 1 to 5 should be considered to havedisclosed subranges such as from 1 to 3, from 1 to 4, from 2 to 4, from2 to 5, from 3 to 5, etc. as well as individual numbers within thatrange, for example 1.5, 2.5, etc. and any whole or partial incrementstherebetween.

All existing subject matter mentioned herein (e.g., publications,patents, patent applications) is incorporated by reference herein in itsentirety except insofar as the subject matter may conflict with that ofthe present invention (in which case what is present herein shallprevail). The referenced items are provided solely for their disclosureprior to the filing date of the present application. Nothing herein isto be construed as an admission that the present invention is notentitled to antedate such material by virtue of prior invention.

Reference to a singular item, includes the possibility that there areplural of the same items present. More specifically, as used herein andin the appended claims, the singular forms “a,” “an,” “said” and “the”include plural referents unless the context clearly dictates otherwise.It is further noted that the claims may be drafted to exclude anyoptional element. As such, this statement is intended to serve asantecedent basis for use of such exclusive terminology as “solely,”“only” and the like in connection with the recitation of claim elements,or use of a “negative” limitation. Unless defined otherwise, alltechnical and scientific terms used herein have the same meaning ascommonly understood by one of ordinary skill in the art to which thisinvention belongs.

Reference to the phrase “at least one of”, when such phrase modifies aplurality of items or components (or an enumerated list of items orcomponents) means any combination of one or more of those items orcomponents. For example, the phrase “at least one of A, B, and C” means:(i) A; (ii) B; (iii) C; (iv) A, B, and C; (v) A and B; (vi) B and C; or(vii) A and C.

In understanding the scope of the present disclosure, the term“comprising” and its derivatives, as used herein, are intended to beopen-ended terms that specify the presence of the stated features,elements, components, groups, integers, and/or steps, but do not excludethe presence of other unstated features, elements, components, groups,integers and/or steps. The foregoing also applies to words havingsimilar meanings such as the terms, “including”, “having” and theirderivatives. Also, the terms “part,” “section,” “portion,” “member”“element,” or “component” when used in the singular can have the dualmeaning of a single part or a plurality of parts. As used herein, thefollowing directional terms “forward, rearward, above, downward,vertical, horizontal, below, transverse, laterally, and vertically” aswell as any other similar directional terms refer to those positions ofa device or piece of equipment or those directions of the device orpiece of equipment being translated or moved.

Finally, terms of degree such as “substantially”, “about” and“approximately” as used herein mean the specified value or the specifiedvalue and a reasonable amount of deviation from the specified value(e.g., a deviation of up to ±0.1%, ±1%, ±5%, or ±10%, as such variationsare appropriate) such that the end result is not significantly ormaterially changed. For example, “about 1.0 cm” can be interpreted tomean “1.0 cm” or between “0.9 cm and 1.1 cm.” When terms of degree suchas “about” or “approximately” are used to refer to numbers or valuesthat are part of a range, the term can be used to modify both theminimum and maximum numbers or values.

This disclosure is not intended to be limited to the scope of theparticular forms set forth, but is intended to cover alternatives,modifications, and equivalents of the variations or embodimentsdescribed herein. Further, the scope of the disclosure fully encompassesother variations or embodiments that may become obvious to those skilledin the art in view of this disclosure.

We claim:
 1. An adjustable static-focus intraocular lens, comprising: anoptic portion; and a peripheral portion coupled to the optic portion,wherein the peripheral portion comprises a composite material comprisingan energy absorbing constituent and a plurality of expandablecomponents, and wherein a base power of the optic portion is configuredto change in response to an external energy directed at the compositematerial.
 2. The adjustable static-focus intraocular lens of claim 1,wherein the expandable components are expandable microspheres, andwherein each of the expandable microspheres comprises a blowing agentcontained within a thermoplastic shell.
 3. The adjustable static-focusintraocular lens of claim 1, wherein the base power of the optic portionis configured to change between about 0.05 D to about 0.5 D in either apositive or negative direction in response to pulses of the externalenergy directed at the composite material.
 4. The adjustablestatic-focus intraocular lens of claim 1, wherein the external energy islaser light having a wavelength of between about 488 nm to about 650 nm.5. The adjustable static-focus intraocular lens of claim 1, wherein theexternal energy is laser light having a wavelength of between about 946nm to about 1120 nm.
 6. The adjustable static-focus intraocular lens ofclaim 1, wherein the external energy is laser light emitted by afemtosecond laser.
 7. The adjustable static-focus intraocular lens ofclaim 1 wherein the composite material is formed as discrete peripheralcomponents such that directing the external energy at one discreteperipheral component causes a change in the base power of the opticportion and directing the external energy at another discrete peripheralcomponent also causes a change in the base power of the optic portion.8. The adjustable static-focus intraocular lens of claim 1, wherein theoptic portion comprises an optic fluid chamber and the peripheralportion comprises at least one peripheral fluid chamber in fluidcommunication with the optic fluid chamber.
 9. The adjustablestatic-focus intraocular lens of claim 8, wherein the composite materialis configured as a chamber expander, wherein the chamber expander isconfigured to expand in response to the external energy directed at thechamber expander, wherein expansion of the chamber expander increases avolume of the peripheral fluid chamber, and wherein the base power ofthe optic portion is configured to decrease in response to the externalenergy directed at the chamber expander, and wherein the chamberexpander is configured as an expandable column extending from a chamberanterior wall to a chamber posterior wall.
 10. The adjustablestatic-focus intraocular lens of claim 8, wherein the composite materialis configured as a space-filler, wherein the space-filler is configuredto expand in response to the external energy directed at thespace-filler, and wherein expansion of the space-filler decreases avolume of the peripheral fluid chamber, and wherein the base power ofthe optic portion is configured to increase in response to the externalenergy directed at the space-filler.
 11. The adjustable static-focusintraocular lens of claim 8, wherein the peripheral portion isconfigured as at least one haptic, wherein the peripheral fluid chamberis defined within the haptic, wherein the peripheral fluid chamberextends only partially into the haptic.
 12. A method of post-operativelyadjusting a static focus intraocular lens, comprising: changing a basepower of the static focus intraocular lens by directing an externalenergy at a composite material within a peripheral portion of theintraocular lens, wherein the peripheral portion is coupled to an opticportion disposed radially inward of the peripheral portion, and whereinthe composite material comprises an energy absorbing constituent and aplurality of expandable components.
 13. The method of claim 12, whereinthe optic portion comprises an optic fluid chamber and the peripheralportion comprises at least one peripheral fluid chamber in fluidcommunication with the optic fluid chamber, and wherein the base powerof the intraocular lens changes in response to fluid displacementbetween the optic fluid chamber and the peripheral fluid chamber as aresult of the external energy directed at the composite material. 14.The method of claim 13, wherein about 15 nL of fluid is exchangedbetween the peripheral fluid chamber and the optic fluid chamber inresponse to an expansion of the composite material.
 15. The method ofclaim 12, wherein adjusting the base power of the intraocular lensfurther comprises increasing the base power by directing the externalenergy at the composite material configured as a space-filler positionedwithin a peripheral fluid chamber defined within the peripheral portion.16. The method of claim 12, wherein adjusting the base power of theintraocular lens further comprises decreasing the base power bydirecting the external energy at the composite material configured as achamber expander positioned within a peripheral fluid chamber definedwithin the peripheral portion.
 17. The method of claim 12, furthercomprising adjusting the base power of the intraocular lens by betweenabout 0.05 D to about 0.50 D in either a positive or a negativedirection by directing pulses of the external energy at the compositematerial.
 18. The method of claim 12, further comprising adjusting thebase power of the intraocular lens in total between about 1.0 D andabout 2.0 D in either a positive or a negative direction by directingmultiple pulses of the external energy at the composite material. 19.The method of claim 12, wherein directing the external energy at thecomposite material further comprises directing laser light having awavelength between about 488 nm to about 650 nm at the compositematerial.
 20. The method of claim 12, wherein directing the externalenergy at the composite material further comprises directing laser lighthaving a wavelength between about 946 nm to about 1120 nm at thecomposite material.